document management system (dms) user guidesupport.pharmaready.com/implementation/prsi/user guides...

© 2008 TAKE Solutions, Inc. All Rights Reserved. of 255

Document Management System (DMS)

User Guide

Version 5.0

File: Document Management System User Guide_Version 5.0.doc

Author(s): Kavitha N

Document Version: 2.0

Status: Final

Last Updated: 20thOctober 2011

PharmaReady™ DMS User Guide


Table of Contents

PREFACE ...................................................................................................................... 10

ABOUT THIS USER GUIDE .................................................................................................... 11

Intended Audience ...................................................................................................... 11

Informational Notes .................................................................................................... 11

Notational Conventions................................................................................................ 12

Organization .............................................................................................................. 13

CONTACT DETAILS ............................................................................................................. 14

Support ..................................................................................................................... 14

Documentation ........................................................................................................... 15

1. INTRODUCTION TO THE PHARMAREADY DMS SYSTEM ......................................... 16

1.1 ABOUT THE DMS SYSTEM ............................................................................................ 17

1.2 UNDERSTAND VALUE OF DMS SYSTEM ............................................................................. 17

1.3 UNDERSTAND DMS DATA STRUCTURE ............................................................................. 17

1.4 LOGON TO PHARMAREADY ............................................................................................ 18

2. PHARMAREADY HOME PAGE ................................................................................. 20

2.1 HOME PAGE ITEMS .................................................................................................... 21

2.1.1 Modules ......................................................................................................... 22

2.1.2 Navigations ..................................................................................................... 24

3. DMS MODULE ....................................................................................................... 34

3.1 DMS HOME PAGE SPECIFIC ITEMS ................................................................................. 35

3.1.1 Menu / Sub Menu and Sub Menu Item ................................................................ 36

3.1.2 Dashboard ...................................................................................................... 40

3.1.3 DMS Action Item ............................................................................................. 40

3.1.4 My DMS Quick View List ................................................................................... 41

4. LIBRARIES AND CATEGORIES .............................................................................. 42

4.1 RIGHTS TO THE ADMIN MENU ....................................................................................... 43



4.2 UNDERSTANDING LIBRARIES AND CATEGORIES ................................................................... 44

4.2.1 Library ........................................................................................................... 44

4.2.2 Category ........................................................................................................ 44

4.3 CREATING LIBRARIES ................................................................................................. 45

4.3.1 Admin Libraries Page ....................................................................................... 45

4.3.2 Add New Library Page ...................................................................................... 46

4.4 BUILDING LIBRARY DIRECTORIES ................................................................................... 53


4.4.2 Maintain Library Page ....................................................................................... 53

4.4.3 Folder Maintenance Page .................................................................................. 55

4.5 CLONING LIBRARIES .................................................................................................. 57


4.5.2 Maintain Library Page ....................................................................................... 59

4.5.3 Maintain Library Page (clone) ............................................................................ 60

4.6 CREATING CATEGORIES .............................................................................................. 62

4.6.1 Admin Categories Page..................................................................................... 62

4.6.2 Add New Category Page ................................................................................... 63

5. PEOPLE AND SUPPORTING DATA ......................................................................... 66

5.1 THE BIG PICTURE OF PEOPLE SUPPORTING DATA ................................................................. 67

5.2 UNDERSTANDING DOCUMENT AUDIENCES ......................................................................... 67

5.3 CREATE READER GROUPS ............................................................................................ 68

5.3.1 Admin Reader Groups Page ............................................................................... 68

5.3.2 Add New Reader Group Page............................................................................. 69

5.3.3 Online Report – People by Reader Group ............................................................ 71

5.4 CREATE REVIEWER GROUPS ......................................................................................... 71

5.4.1 Admin Reviewer Groups Page ............................................................................ 72

5.4.2 Add New Reviewer Group Page .......................................................................... 72

5.4.3 Online Report – People by Reviewer Group ......................................................... 74

5.5 CREATE APPROVER GROUPS ......................................................................................... 74



5.5.1 Admin Approver Groups Page ............................................................................ 75

5.5.2 Add New Approver Group Page .......................................................................... 75

5.5.3 Online Report – People by Approver Group ......................................................... 78

5.6 CREATE SITES (OPTIONAL) .......................................................................................... 79

5.6.1 Admin Sites Page ............................................................................................ 79

5.6.2 Add New Site Page .......................................................................................... 79

5.7 CREATE DEPARTMENT ................................................................................................. 81

5.7.1 Admin Departments Page ................................................................................. 81

5.7.2 Add New Department Page ............................................................................... 82

5.8 CREATE PROJECT (OPTIONAL) ....................................................................................... 83

5.8.1 Admin Projects Page ........................................................................................ 83

5.8.2 Add New Project Page ...................................................................................... 84

5.9 UNDERSTAND STANDARD ACCESS ROLES .......................................................................... 87

5.10 CLONING TO CREATE NEW FUNCTIONAL ACCESS ROLES ...................................................... 88

5.10.1 An important note about creating roles from scratch ......................................... 88

5.10.2 Admin Roles Page ......................................................................................... 89

5.10.3 Maintain Roles Page ...................................................................................... 90

5.11 CREATING AND EDITING PEOPLE ................................................................................. 92

5.11.1 Admin People Page ...................................................................................... 93

5.11.2 Add New People Page .................................................................................... 94

5.11.3 Import People from Active Directory .............................................................. 100

5.11.4 Edit Person Details ...................................................................................... 104

5.11.5 Clone a Person ........................................................................................... 105

6. SYSTEM MAINTENANCE AND MONITORING ....................................................... 108

6.1 SYSTEM SETTINGS .................................................................................................. 109

6.1.1 Understand System Settings Page (General) ..................................................... 109

6.1.2 Understand System Settings Page (DMS) ......................................................... 116

6.2 SYSTEM PRINTERS (OPTIONAL) .................................................................................... 118

6.2.1 Add New Printer Page..................................................................................... 119



6.3 REMINDERS (OPTIONAL) ............................................................................................ 120

6.3.1 Add New Reminder Page ................................................................................ 120

6.4 MONITORING ACTIVITY WITH THE AUDIT LOG VIEWER......................................................... 124

6.4.1 Audit Log Viewer Page .................................................................................... 124

6.4.2 Types and Associated Activities ....................................................................... 125

7. CREATE DOCUMENTS.......................................................................................... 128

7.1 ROLES AND WORKFLOW ............................................................................................ 129

7.1.1 DMS Roles .................................................................................................... 129

7.1.2 DMS Workflow ............................................................................................... 130

7.2 CREATING NEW DOCUMENTS ...................................................................................... 131

7.2.1 Create Document Page ................................................................................... 131

7.2.2 Document Properties Page .............................................................................. 134

7.2.3 Work with Documents Page ............................................................................ 147

7.3 CREATING A NEW DOCUMENT USING A TEMPLATE (OPTIONAL) ............................................... 149

7.4 UPLOAD DOCUMENTS IN A BATCH ................................................................................. 152

7.4.1 Batch Upload Page ......................................................................................... 153

8. EDIT, REVIEW & APPROVE DOCUMENTS ............................................................ 159

8.1 DOCUMENT STATUSES .............................................................................................. 160

8.1.1 Document Status, Roles, & the DMS Workflow .................................................. 161

8.2 WORKFLOW NAVIGATION ........................................................................................... 161


8.2.2 DMS Central Page .......................................................................................... 162

8.3 EMAIL NOTIFICATIONS AND WORKFLOW ......................................................................... 163

8.4 CHECKING OUT DOCUMENTS ....................................................................................... 164


8.4.2 Check Out a Document Page ........................................................................... 166

8.4.3 In-Place Editing (Non-Hosted Clients)............................................................... 167

8.4.4 Saving the Document ..................................................................................... 168



8.5 CHECKING IN DOCUMENTS ......................................................................................... 169


8.5.2 Check In a Document Page ............................................................................. 171


8.6 UPDATING ACTIVITY MODE ........................................................................................ 173

8.6.1 Work with Document Page .............................................................................. 173

8.6.2 Document Properties Page .............................................................................. 175

8.7 REVIEWING DOCUMENTS ........................................................................................... 176

8.7.1 DMS Central Page .......................................................................................... 177

8.7.2 Opening/Saving the Document ........................................................................ 178

8.7.3 DMS Central Page .......................................................................................... 179

8.7.4 Review a Document Page ............................................................................... 181

8.8 APPROVING DOCUMENTS ........................................................................................... 182

8.8.1 DMS Central Page .......................................................................................... 183

8.8.2 Opening/Saving the Document ........................................................................ 184

8.8.3 Central Page ................................................................................................. 185

8.8.4 Approve a Document Page .............................................................................. 185

9. PUBLISH, DISTRIBUTE & READ DOCUMENTS ..................................................... 187

9.1 PUBLISHING DOCUMENTS .......................................................................................... 188


9.1.2 Publish a Document Page ............................................................................... 189

9.2 DISTRIBUTING DOCUMENTS ....................................................................................... 194


9.2.2 Distribute a Document Page ............................................................................ 195

9.3 READING REQUIRED DOCUMENTS ................................................................................. 196

9.3.1 Central Page ................................................................................................. 196

9.3.2 Reading a Document ...................................................................................... 197

9.4 VERIFYING READING A DOCUMENT ................................................................................ 198

9.4.1 Central Page ................................................................................................. 198



9.4.2 Verify Read Page ........................................................................................... 198

9.5 LOCATING DOCUMENTS ............................................................................................. 199

9.5.1 Browse Documents Page ................................................................................ 200

9.5.2 The Search Page ........................................................................................... 201

10. DIFFERENT TYPES OF REPORTS ......................................................................... 204

10.1 ARCHIVE REPORT ................................................................................................. 205

10.2 BATCH EXPORT REPORT ......................................................................................... 206

10.3 BATCH UPLOAD REPORT ......................................................................................... 207

10.4 DATE DUE REVIEW REPORT ..................................................................................... 208

10.5 DELEGATED APPROVALS REPORT ............................................................................... 209

10.6 DOC APPROVE HISTORY REPORT ............................................................................... 210

10.7 DOC CHECK IN OUT SUM........................................................................................ 211

10.8 DOC FOLDER LIST REPORT ...................................................................................... 212

10.9 DOC REVIEW HISTORY REPORT................................................................................. 213

10.10 DOC WORKFLOW ASSIGN ..................................................................................... 214

10.11 PENDING DOC ACTION ........................................................................................ 215

10.12 PEOPLE WORKFLOW ASSIGN ................................................................................. 216

10.13 PUB DOC BY READERS ........................................................................................ 217

10.14 PUBLISHED DOC LIST ......................................................................................... 218

10.15 READ VERIFY SUMMARY ....................................................................................... 219

10.16 ACCESS REPORT ............................................................................................... 221

10.17 DELEGATION REPORT .......................................................................................... 222

10.18 READ VERIFY ACTIVITY ....................................................................................... 222

10.19 READER SUMMARY ............................................................................................. 223

10.20 REQUIRED READING REPORT ................................................................................. 225

10.21 RETENTION DATE .............................................................................................. 226

10.22 AUDIT LOG LISTING ........................................................................................... 227

10.23 ACCESS RIGHTS REPORT ..................................................................................... 228

10.24 DATA SUMMARY REPORT ...................................................................................... 229



10.25 PEOPLE BY DEPARTMENT ...................................................................................... 230

10.26 PEOPLE BY PROJECT ........................................................................................... 231

11. ADDITIONAL DOCUMENT FUNCTIONALITY ........................................................ 232

11.1 ARCHIVE DOCUMENTS ........................................................................................... 233

11.2 CREATING DOCUMENT NUMBERS MANUALLY .................................................................. 234

11.2.1 Doc Number Manager Page .......................................................................... 235

11.2.2 Add a New Document Number Page .............................................................. 236

11.3 CREATING DOCUMENT TEMPLATES ............................................................................. 238

11.3.1 Doc Template Manager Page ........................................................................ 239

11.3.2 Add a New Document Template Page ............................................................ 239

11.4 CREATING DOCUMENT PROPERTIES TEMPLATES .............................................................. 242

11.4.1 Admin Doc Prop Templates Page ................................................................... 242

11.4.2 Add New Doc Prop Template Page ................................................................. 243

11.4.3 Admin Doc Prop Template Page .................................................................... 253

12. APPENDIX .......................................................................................................... 254

12.1 GLOSSARY ......................................................................................................... 254



Copyright

Copyright © 2008 “TAKE Solutions, Inc.”. All rights reserved.

The information in this user guide is protected under the terms of the TAKE Solutions License Agreement.

There are specific copy restrictions in the license agreement. All information supplied in this user guide is to

be treated as TAKE Solutions, Inc. confidential information. No part of this document may be reproduced,

stored in or introduced into a retrieval system, transmitted into any form or by any means (electronic,

mechanical, photocopy, recording, or otherwise) or for any other purpose, without the express or written

permission of “TAKE Solutions”.

Disclaimer

Information in this document is subject to change without notice and should not be constructed as a

commitment on the part of the “TAKE Solutions”.

“TAKE Solutions” does not assume any responsibility or make any warranty against errors that may appear in

this document and disclaims any implied warranty of merchantability or fitness for a particular purpose. If

you find any problems, please report them to “TAKE Solutions” in writing immediately.

Trademark Notice

The names of actual companies, brands and products mentioned within this document are the trademark or

registered trademark of their respective owners. The examples given, as companies, organizations, products,

people and events, depicted are fiction. No association with any real company, organization, product,

person, or event is intended or should be inferred. Any rights not expressly granted herein are reserved.



PREFACE

Welcome to the PharmaReady Document Management System

(DMS) User Guide.

This User Guide contains the most up-to-date information on the

PharmaReady Document Management System (will be mentioned as

DMS going forward) and provides all the details pertaining to the

DMS system.

The following topics are covered in this section below.

Topic Page

About this User Guide 11

o Intended Audience 11

o Informational Notes 11

o Notational Conventions 12

o Organization 13

Contact Details 14

o Support 14

o Documentation 15



About This User Guide

This User Guide contains fundamental information necessary for all users of the PharmaReady

Document Management System module, describes all the features available in the DMS System,

providing step-by-step instructions to assist the user in working on the DMS Application

independently.

Intended Audience

This User Guide is intended for audiences who are associated with pharmaceutical organizations,

and the DMS System is designed for organizations conducting business in accordance with United

States Food and Drug Administration (USFDA) regulations and other federal laws concerning the

use of computerized systems for data management.

Informational Notes

The following reader aids are used in this User Guide:

Reader Aid Description

Note : Contains supplemental information.

Tip : Contains methods of performing a task more quickly.

Important : Contains information that is essential to complete a task.

See also : Contains references to other sources of information.

Caution : Contains valuable information about loss of data; be sure to read this

information carefully.

Specific : Feature is explained, but applicable for a different Module(e.g.

Training Management System [TRMS Module]).



Notational Conventions

The following style conventions and terminologies are used in this User Guide:

Element Meaning Examples

Bold font Table Captions, Figure

Captions, Table

Headings

Table 2.1:Central Page Items

Figure 2.1: Logon Page

Italic font Page Name Logon page

Central page

Underline with

Blue color font

Hyperlinks Chapter1 :Introduction to the PharmaReady DMS

System

Numbers Pointed: For easy understanding, numbers are marked around fields in the

screenshots, and their corresponding functionality or usages are explained below them along

with their respective numbers.



Organization

The User Guide is organized as chapters. The following lists the chapters in this User Guide, and a

brief description of each chapter’s contents:

Chapter Description

Chapter 1 : Introduction to the

PharmaReady DMS System

This Chapter provides the fundamental information

necessary for all users of the PharmaReady Document

Management System (DMS) module.

Chapter 2 : PharmaReady Home Page

The PharmaReady Home Page serves as the starting

point for all the PharmaReady functions It describes

about the navigation to modules & Menu navigation.

Chapter 3 : DMS Module

Describes Menu and Sub Menu Navigation inside DMS,

Dashboard, DMS Action item and My DMS Quick view

list.

Chapter 4 : Libraries and Categories

Describes rights to the Admin menu, how to create

libraries, build library directories, clone libraries and

create categories.

Chapter 5: People and Supporting

Data

Describes how to create a reader group, site,

department, project, explains standard access roles,

clone and create new functional roles and how to

create and edit people.

Chapter 6 : System Maintenance and

Monitoring

Describes global and DMS specific system settings,

setup system printers, reminders, and monitor system

activity with the audit log viewer.

Chapter 7 : Create Documents

Describes roles and workflow, how to create new

document, new document using template, and upload

documents in a batch.

Chapter 8 : Edit, Review and Approve

Documents

Describes document status and workflow, email

notifications, how to checkout and check-in a

document, update document’s activity mode, review a

document and approve a document.



Chapter 9 : Publish Distribute and

Read Documents

Describes how to publish a document, distribute a

document, read a document, verify and locate

documents at every life cycle stage.

Chapter 10 :Different Types of

Reports

Describes all delivered reports pertaining to

documents, people, and monitoring system activity are

accessed from the Reports menu.

Chapter 11 : Additional Document

Functionality

Describes how to create doc no’s manually, document

templates and doc. properties template

Chapter 12 :Appendix

Describes how to publish a document, distribute a

document, read a document, verify and locate

documents at every life cycle stage.

Contact Details

Support

TAKE Solutions’ applications are designed and developed to provide users with high quality, easy–

to-use products. However, should any user experience a problem with any application, the TAKE

Solutions Support Center is ready to assist users in identifying and resolving any issue.

Contact Information

Asia Pacific - Registered Office

Chennai, India 2nd Floor, Block - A1

Shriram "The Gateway SEZ",

No.16, GST Road, Perungalathur,

Chennai-600063, India

Tel : +91 44 4590 9367/9369

Fax : +91 44 4590 9099

North America – Head Quarters

Princeton, NJ

502 Carnegie Center, Suite 100

Princeton, NJ 08540

Tel : +1 609 720 1002

Fax : +1 609 720 1003

Email: [email protected]

Website: www.takesolutions.com

mailto:[email protected]

http://www.takesolutions.com/



Documentation

TAKE Solutions appreciates any comments and/or suggestions regarding this user guide. Any

provided input will have a direct impact on future releases of user guides. Please send any

comments or suggestions regarding product documentation to

support.PharmaReady@TAKESolutionscom.

mailto:support.PharmaReady@TAKESolutionscom



CHAPTER 1

1. Introduction to the

PharmaReady DMS System

About this Chapter

The PharmaReady Document Management System (DMS) is

designed for organizations conducting business in accordance

with United States Food and Drug Administration (USFDA)

regulations and other federal laws concerning the use of

computerized systems for data management.

This chapter describes how to get started and navigate within the

DMS System.

This chapter includes the following sections:

Contents

Topic Page

About the DMS System 17

Understand value of DMS system 17

Understand DMS data structure 17

Pre – Installation Requirements 18

Logon to PharmaReady 19

3. Introduction to the PharmaReady DMS System PharmaReady™ DMS User Guide


1.1 About the DMS System

PharmaReady DMS is a web-based Document Management System that automates and

seamlessly manages document control process to ensure compliance with international regulatory

authorities like FDA (USA), EMEA (European Union), Health Canada (Canada), TGA (Australia),

and HSA (Singapore).

1.2 Understand Value of DMS System

Many organizations are required by the FDA and other federal laws to implement controls for the

software and systems that manage data as part of their operations and product development.

One such regulation is Title 21 CFR Part 11, which deals with the FDA guidelines on electronic

records and electronic signatures in the United States. Part 11, as it is often called, defines the

criteria under which electronic records and electronic signatures are considered to be trustworthy,

reliable, and equivalent to paper records.

The PharmaReady DMS ensures compliance to Part 11 and other federal laws through:

Technical FDA Compliance.

Role-based people management; each user must have a unique Logon ID and cannot be

logged into PharmaReady at more than one workstation.

Document security through use of electronic signatures (e-signatures).

Role-based, system-driven workflow that ensures document and version management

while creating necessary audit trails.

By managing your document lifecycle with the PharmaReady DMS, you can easily provide auditors

precise document audit logs and reports, including information on which users have read a

document or played a role in the document lifecycle.

1.3 Understand DMS Data Structure

Before we begin viewing and entering data into the PharmaReady DMS, let’s discuss how data is

housed in the DMS.

As you would imagine with a document management system, the structure of the DMS surrounds

the documents themselves. In terms of organization, documents are housed in libraries and typed

by category.

1. Introduction to PharmaReady DMS System PharmaReady™ DMS User Guide


From a user perspective, each person is assigned one or more roles and is a member of one or

more document audiences. The roles and membership enable document workflow.

Figure 1.1: DMS Data Structure

1.4 Logon to PharmaReady

PharmaReady is a Web-based application. The logon screen and all PharmaReady pages are

accessed via a Web Browser.

1. Launch a browser window and enter the appropriate URL.

This opens a Logon page and prompts you for your Logon Id and Password, as shown in the

below figure:

Library Document People

Role

Audience

Membership

Category

1. Introduction to PharmaReady DMS System PharmaReady™ DMS User Guide


Figure 1.2: Logon Page

Note: Each DMS user has a unique Logon ID that determines their access to various areas of the

system. To get the Logon ID and Password, contact your System Administrator.

Caution: For security purposes, you cannot be logged into PharmaReady at more than one

workstation.

2. In the Logon ID field, type your Login ID.

3. In the Password field, type your Password.

4. Click Logon button, which opens the PharmaReady Home Page as shown below:

Note: Logon Text is displayed as configured in Admin > System Settings.



CHAPTER 2

2. PharmaReady Home Page

About this Chapter

The PharmaReady Home Page serves as the starting point for all

the PharmaReady functions.


Contents

Topic Page

Home Page Items 21

o Modules 22

o Navigations 24

2. PharmaReady Home Page PharmaReady™ DMS User Guide


2.1 Home Page Items

Figure 2.1: PharmaReady Home Page

The buttons, menu and navigations present in the PharmaReady Home Page Items are explained

in the Table below:

Table 2.1: PharmaReady Home Page Items

PharmaReady Home Page Items

A. Different Types of Modules

1. DMS

2. eCTD

3. SPL

4. TRMS



B. Menu and Sub Menu

5. Reports

6. Admin

C. Common Page Buttons & Navigations

7. Help

8. My Prefs

9. About

10. Log Off

11. Home (Pharma Ready)

12. User

13. Search

14. Home (DMS)

2.1.1 Modules

As specified in the table above, there are four different modules available in PharmaReady. These

are listed below one-by-one.

Table 2.2: Four types of Modules

# Item Description& Instruction

1 DMS Click on the required module to work on the specific module.

This user guide deals with the DMS Module.

Specific: The instructions for the other 3 modules (eCTD,

SPL and TRMS) are explained in the respective

Help Guide.

2 eCTD

3 SPL

4 TRMS



2.1.1.1 DMS

Click on the DMS module which opens the DMS Home Page as shown in the figure below:

Figure 2.2: PharmaReady DMS Home Page

Note: The menu and all the instructions pertaining to DMS are explained in this user guide.

2.1.1.2 eCTD

Click on the eCTD module which opens the eCTD Home Page as shown in the figure below:

Figure 2.3: PharmaReady eCTD Home Page



2.1.1.3 SPL

Click on the SPL module which opens the SPL Home Page as shown in the figure below:

Figure 2.4: PharmaReady SPL Home Page

2.1.1.4 TRMS

Click on the TRMS module which opens the TRMS Home Page as shown in the figure below:

Figure 2.5: PharmaReady TRMS Home Page

2.1.2 Navigations

The two main navigation components of PharmaReady are menu items (Main Menu and Sub-

Menu) and Page Elements.

2.1.2.1 Main Menu and Sub Menu

The PharmaReady Main Menu appears at the top of every PharmaReady page and is the primary

means of navigation throughout the system.



The Sub Menu is displayed below the Main Menu, as shown in the below example:

Figure 2.6: Main Menu and Sub Menu(Example)

The Main Menu and the Sub Menu appearing below the Main menu are shown in the table below:

Table 2.3: Main Menu / Sub Menu &its Description

Main Menu Description Sub Menu Description

Reports

All delivered reports

pertaining to

documents, people,

and monitoring system

activity are accessed

from the Reports

menu.

Audit Log Listing Used to view audit log listing report

Access Rights Used to view Access Rights report

Data Summary Used to view Data Summary report

People by

Department

Used to view People by Department

report

People by Project Used to view People by Project

report

Admin

All system

administration

functions are accessed

from the Admin menu.

Audit Log Viewer Used to create Audit Log Viewer

People Used to create People

Departments Used to create Departments

Sites Used to create Sites

Projects Used to create Projects



Roles Used to create Roles

Lookup Tables Used to create Lookup Tables

System Printers Used to create System Printers

System Settings Used to create System Settings

Regulatory

Identifiers

Used to create Regulatory

Identifiers

My Preferences Used to access the My Preferences

Note : For users without administrative rights, My Preferences Menu item is alone available under

admin menu.

Note : The menu items and sub-items will vary depending on your user rights.

Caution : Do not use Web Browser buttons (Back, Forward, Home, etc), to navigate within

PharmaReady.

2.1.2.2 Page Elements

Elements appearing on PharmaReady page allow you to orient yourself and/or serve as a means

of navigation. These elements are explained in the below table.

Table 2.4: Page Elements and Description

Page Element Description

User Name Your user name (with which you entered into the system)is always

displayed in the User Identification area of the menu bar (top right



corner of the page).

Common Page Buttons

Present at the top right corner of the page.

These buttons are common to every page. The Function and page

accessed by each button is discussed in the next section under the

heading “Common Page Buttons”.

Other Page Elements

Hyperlinks

As a Web-based system, PharmaReady enables text as hyperlinks

to allow you easy access to information. For example, when

working on the content of a label, the label name at the top of the

page is an active link to the label’s properties.

Icons

When an icon appears on page, it is frequently also a means of

accessing a page or function. For example, users working with a

document can view its properties by clicking the document

properties icon: .

Checkboxes Certain checkboxes, when checked, launch new pages in the DMS

Module after the initial page is submitted to the database.

2.1.2.2.1 Common Page Buttons

A set of commonly used buttons appears at the top of every page in PharmaReady, which enables

quick access to frequently used features.

These common page buttons are explained in the below table:

Table 2.5: Common Page Buttons and Description

Button Description

Help Enables you to access context-sensitive help for the page you are

currently viewing.

My Prefs Enables you to add to and update your user profile and set specific

user preferences.



About Enables to display the version, build, license, module(s), and other

installation information for your current PharmaReady session.

Log off Enables to end your PharmaReady Session.

Home Button

(PharmaReady) Enables to view the PharmaReady Home Page.

Home Button (Module) Enables to view the Module Home Page (based on the module the

user had selected).

Search Enables you to perform search on a word or words in a document.

Search is not valid for a DMS-only implementation.

The usage of these buttons is explained below in detail:

2.1.2.3 Help Button

Click this Help button, to open the Help window for the specific PharmaReady page you are

currently viewing.

A sample is shown below:

Figure2.7: Help Window



2.1.2.4 My Preferences Button

The My Preferences page allows you to add to and update your personal profile. It is also where

you select user system settings such as the date and time format and system password

Click this My Preferences button, which opens the My Preferences page, as shown in the figure

below:

Figure2.8: My Preferences Page

Tip : You can also access your My Preferences page by selecting Admin > Preferences in the

PharmaReady Home page.



The fields present in the My Preferences page are explained in the below table:

Table 2.6: My Preferences Fields & Description

# Fields Description / Instruction

1 My Information

Enter your First Name, Last Name and Email address which are

mandatory fields.

Enter your Unit Name (e.g. Data Management, Reg. Affairs, etc.)

Enter your primary and secondary Phone number.

Select the Number of Rows to indicate the number of table entries to

display on PharmaReady pages before automatic paging starts.

Check the Email Notify checkbox, to receive emails from PharmaReady,

notifying you of system events.

Select the required Date Format and Time format, which would get

displayed throughout the application.

Select a default printer to override the default system printer of

PharmaReady. The printer selected here becomes the default for the

Document Direct-Print feature in PharmaReady. The Document Direct-

Print functionality prints a document directly from PharmaReady without

viewing and is available whenever you see the Printer icon: .

Note : The default printer field will display printers added to the

PharmaReady Server. Your organization may not use this feature.

2 Change

Password

This is used to set a new password. PharmaReady may require you to change

your Password on a scheduled basis or your System Administrator may

require you to reset it. Follow these steps to change your Password:

Enter your Current Password. When you enter the Password, the

characters are hidden.

Enter your New Password.

Retype your new password, in the Confirm New Password field.

You can use the new password to logon to the system.



3

Delegate DMS

Review Authority

Select one person who has the right to perform reviews and approvals

during a defined absence. Delegate DMS

Approval

Authority

4 Save Changes

Click the Submit button to save the specified information or the Cancel

button to end the function, which will not save the changes you have

entered.

2.1.2.5 About Button

Click this About button, which displays the version, build, license, module(s), and other

installation information for your current PharmaReady session, as shown in the figure below:

Figure 2.9: About Window

Tip : Click the Close button to return to the PharmaReady home page.



2.1.2.6 Logoff Button

The Log Off button immediately cancels your logon session and prevents others from accessing

the system using your session.

Click this button, which displays the below message:

Click the OK button to end the PharmaReady Session or the Cancel button to proceed within

the system.

2.1.2.7 Home Button (PharmaReady)

Click this Home button, which displays the PharmaReady Home page as shown below:

Figure 2.10: PharmaReady Home Page

2.1.2.8 Search Button

To perform a search on a word or words in a document, enter the text in the Srch(Search)

field and click the Srch text.

Caution : When you navigate to a new webpage, you will not log off of PharmaReady.

You should always click the Log Off button, to end your PharmaReady session.



To perform an advanced search using multiple criteria, click the Srch text to display the

Search page.

Note : Search is valid only for DMS implementation.

2.1.2.9 Home Button (Module Main Page)

This Home button takes the user to the Home Page of the selected Module. For example, if the

user is in DMS Module, then DMS Module Main page is displayed.

Note : This button does not get highlighted, if the user has not selected any of the modules.

A sample is shown below:

Figure 2.11: DMS Module Main Page



CHAPTER 3

3. DMS Module

About this Chapter

PharmaReady DMS is a web-based Document Management

System that automates and seamlessly manages document

control process to ensure compliance with the international

regulatory authorities like FDA (USA), EMEA(European Union),

Health Canada (Canada), TGA (Australia), and HSA (Singapore).

As specified earlier, this user guide deals with the DMS Module.


Contents

Topic Page

Menu and Sub Menu 38

Dashboard 42

DMS Action 42

My DMS Quick View ‘List 43

3. DMS Module PharmaReady™ DMS User Guide


3.1 DMS Home Page Specific Items

Figure 3.1: DMS Home Page Specific Items



The buttons, menu and navigations present in the PharmaReady DMS Home Page Items are

explained in the Table below:

Table 3.1: DMS Home Page Specific Items

DMS Home Page Specific Items

Menu and Sub Menu

1. DMS

2. Reports

3. Admin

Others

4. Dashboard

5. DMS Action

6. My DMS Quick View List

3.1.1 Menu / Sub Menu and Sub Menu Item

The PharmaReady DMS Main Menu appears at the top and is the primary means of navigation for

DMs.

The Sub Menu is displayed below the Main Menu and the Sub Menu Item is displayed below the

sub menu, as shown in the below example:



Figure 3.2: Main Menu / Sub Menu and Sub Menu Item(Example)

The Main Menu and the Sub Menu appearing below the Main menu are shown in the table below:

Table 3.2: Main Menu / Sub Menu & its Description

Main Menu Description Sub Menu Description

DMS

This menu is used for

Document creation,

Browse Documents

Batch Upload,

Documents archive,

Doc Numbers /

Templates

Central Used to view the DMS Central Page

Browse

Documents

Used to browse documents, print,

read and verify the documents that

are read

Create Document Used to create documents

Batch Upload Used to upload batch of documents

Work with

Documents

Used to work with the documents



Archive

Documents

Used to archive documents

Doc Numbers Used to create/manage document

numbers

Doc Templates Used to create/manage document

templates

Reports

All delivered reports

pertaining to

documents, people,

and monitoring system

activity are accessed

from the Reports

menu.

Archive Report Used to view audit log listing report

Batch Export

Report

Used to view Batch Export Report

Batch Upload

Report

Used to view Batch Upload Report

Date Due Review Used to view Date Due Review

Report

Delegated

Approvals

Used to view Delegated Approvals

Doc Approve

History

Used to view Doc Approve History

Report

Doc Chk InOut

Sum

Used to view Doc Check In and

Check Out Sum report

Doc Folder List Used to view Doc Folder List report

Doc Review

History

Used to view Doc Review History

Doc Workflow

Assign

Used to view Doc Workflow Assign

Pending Doc

Action

Used to view Pending Doc Action

report

People Wrkflw

Assign

Used to view People Workflow

Assign report



Pub Doc by

Readers

Used to view Pub Doc by Readers

report

Published Doc List Used to view Published Doc List

report

Read Verify

Summary

Used to view Read Verify Summary

report

Access Report Used to view Access Report

Delegation Report Used to view Delegation Report

Read Verify

Activity

Used to view Read Verify Report

Reader Summary Used to view Reader Summary

Report

Required Reading Used to view Required Reading

report

Retention Date Used to view Retention Date report

Admin

All system

administration

functions are accessed

from the Admin menu.

Audit Log Viewer Used to create Audit Log Viewer

Groups Used to create/Manage Approver

Group, Reader Group and Reviewer

Group

Categories Used to create/Manage Categories

Libraries Used to create/Manage Libraries

Doc Prop

Templates

Used to create/Manage Doc Prop

Templates

Roles Used to create/Manage Roles

System Settings Used to assign System Settings



Note : The menu items and sub-items will vary depending on your user rights.

3.1.2 Dashboard

DMS Action Item tab is explained in the below table:

Table 3.3: DMS Home Page Items

# Item Description

3 Dashboard The number of Documents, number of People Logged on, number

of Locked Accounts and Pending Action Items are displayed in

the Dashboard, as shown in the sample below:

3.1.3 DMS Action Item

DMS Action Item tab is explained in the below table:


# Item Description

3 DMS Actions This section contains a list of documents needing your attention.

The items in your list are generated automatically by

PharmaReady according to your role(s) and current document

activity.

PharmaReady can also be configured to send email notifications

for required actions. Each user can determine whether they want

to receive user email notifications.



3.1.4 My DMS Quick View List

My DMS Quick View List Item is explained in the below table:


# Item Description

4 My DMS Quick View

List

This section, commonly referred to as the Quick View, is a list of

documents selected by you for the purpose of quick access. You

can think of Quick View as your favorites list in PharmaReady.

Any document to which you have rights can be added to your

Quick View list.

Posting to Quick View is discussed in detail, in this user guide as

you go along.



CHAPTER 4

4. Libraries and Categories

About this Chapter

One of the key decisions made while implementing a Document

Management System (DMS) is the organization of documents.

In the PharmaReady DMS, the basis for this organization is

libraries, which house your documents, and categories, which

“type” your documents. In this chapter, Administrators will

learn to set up both structures in the DMS.


Contents

Topic Page

Rights to the Admin Menu 45

Understanding Libraries and Categories 46

Creating Libraries 47

Building Library Directories 55

Cloning Libraries 59

Creating Categories 64

4. Libraries and Categories PharmaReady™ DMS User Guide


4.1 Rights to the Admin Menu

Before we begin working with libraries and categories, a brief discussion of the Admin menu is

warranted.

All the pages required for administration of the DMS are accessed via the Admin menu, which

displays the options as shown below:

Figure 4.1: Admin menu Options

Visibility and access to Admin menu items is determined by role, as shown in the table below:

Table 4.1: DMS Role and Menu Items

DMS Role Accessible Menu Items

System Administrator All Admin menu items

People Administrator People, Sites, and Departments

Library Admin Audit Log Viewer; all items under the Documents menu

All Roles My Preferences

Important : At a minimum, you must have libraries, categories, and people set up in the system

before users can begin managing their documents in the DMS.

Additional features and functionality are optional, including setup and use of

departments, projects, sites, and reader groups (although reader groups are highly

recommended).



4.2 Understanding Libraries and Categories

Libraries and categories are the two main organizational structures for documents in the DMS.

Every document in the DMS is assigned to a single library and category.

The distinction between libraries and categories lies in organization versus typing based on

business purpose.

4.2.1 Library

Definition : A Library is a repository for documents within PharmaReady. Libraries contain

folders and subfolders that house documents, so a simple way to visualize a

library is to picture a filing cabinet.

Below is an example of libraries in PharmaReady. Your organization will establish its own set of

libraries.

4.2.2 Category

Definition : Category represents a means of typing a document based on business need and spans across libraries.

For example, you do not need to house all of your Standard Operating Procedures (SOP) in a

single library. Instead, create a category of SOP. Your SOPs can then be housed in any library

while maintaining their distinction as a Standard Operating Procedure.



4.3 Creating Libraries

Libraries act as repositories for documents within PharmaReady. Every document in the system must

be assigned to a library, thus libraries must exist before users can create documents.

Libraries can support hierarchical folder structures for virtual cataloging and storage of documents.

Important : This activity is performed by the System Administrator.

4.3.1 Admin Libraries Page

The button to add a new library is located at the bottom of the Admin Libraries page.

1. Select Admin>Libraries in the DMS Home page.

This opens the Admin Libraries page, as shown in the figure below:

Figure 4.2: Admin Libraries Page

2. Click the Add New Library button at the bottom of the Admin Library page.

This displays the Add New Library page as shown below:



4.3.2 Add New Library Page

Figure 4.3: Add New Library Page



All the setup required to create a new library is performed on the Add New Library page. The

page is logically divided into the following sections as explained in the table below:

Note : For easy understanding, the Add New Library page(Screen Shot)is separated and

explained based on the sections specified above.

Table 4.2: Add New Library Page - Sections

Section Description

1. Library Information

The Library Name and Description fields in this section are the only values required to save a

library to the DMS.

Beyond the required fields, the Library Information section houses values used when creating

documents in this library.

For example, you can enable auto-numbering for documents in this library and set the

prefix and start number to establish the library’s default numbering. You also have the

option of selecting a set of document properties that can be used to populate the Document

Properties page when creating a new document.



2. Workflow Settings

The Workflow Settings section allows you to establish rules and provide information to users in

support of document workflow. Options include requiring approvals prior to publishing and

including comments and reports in the notification emails triggered by events in the document

life cycle.

Options available in the Workflow Settings section are explained below:



Table 4.3: Options in Workflow Settings

Checkbox Description

Require Approval to Publish Documents Requires that every document in the library

have all approvals prior to publishing.

Require Child Documents be Published

for Virtual Document to be Published

Requires that all child documents of a virtual

document be published before the parent can be

published.

Include Document Description in

Workflow Emails

Includes the Description field from the

Document Properties page in all workflow

emails, including Read Required, Review,

Approve, Publish, and Reminders.

Include Check In/Out Comments in

Review Email

Attaches a PDF copy of the Document Check

In/Out Summary report to the email sent to

Document Reviewers when the document is

placed in Review mode.

Include Review Comments in Review

Complete Email

Attaches a PDF copy of the Document Review

History report to the email sent to Document

Owners when all reviews are completed for a

document.

Include Approve Comments in Approve

Complete Email

Attaches a PDF copy of the Document Approval

History report to the email sent to Document

Owners when all approvals are completed for a

document. Will also send the same report

attached to an email when a document is not

approved.



3. PDF Publishing Defaults

The PDF Publishing Defaults section allows you to enable or disable specific functions related to

creating portable documents.

Options available in the PDF Publishing Defaults section are explained below:

Table 4.4: Options in PDF Publishing Defaults


Publish Watermark The text here automatically populates the PDF

options on the Document Properties page when

publishing a document to this library. You can

edit or omit this text per document prior to

publishing.

Include Watermark test Applies the text entered in the Published

Watermark field as a watermark on each page

of the final published document.

Include version and published Date

watermark

Applies the version number and date the

document was published as a watermark on

each page of the published document.

Create Bookmarks from Style Settings

(for Word Docs Only)

Creates hyperlinks in the PDF file based on

predefined styles from Microsoft Word.



Append Document Control information

page

Adds a final page to the published document

providing Document Control data (doc #,

version, library, author, key dates, and reader

rights).

Prevent PDF from being Printed Allows readers to view the document, but

disables printing options.

Prevent PDF contents from being

Copied or Saved as another Format

Allows readers to view the document, but

disables copy and save options in Adobe

Acrobat.

Include Printed Date in Document Includes date on document when printed.

4. E-Signature Settings

Each library has its own set of e-signatures which you can customize in terms of which actions

are required and the possible meanings of each action.



5. Custom Document Property Fields

You have the option of creating custom fields unique to each library in PharmaReady.

Four types of fields are available as custom fields. A library can have multiple custom fields of a

single type, and any field can be set as required. Not only can you record your specific data

using custom fields, these fields are added to the Search page, thus enabling you to perform

searches using custom field values.

6. Save Changes

After entering Library details and additional values according to the desired set up for this

library, click the Submit button in the Add New Library page, to save the library to

PharmaReady.

Once when the details are submitted, you are returned to Admin Libraries page, which displays

the added library, as shown in the sample below:




4.4 Building Library Directories

Important : This activity is performed by a Library or System Administrator.

Once a library is saved to PharmaReady, you can build its hierarchical folder structure.

Documents can be assigned to any level in the hierarchy.

You also have the option of pulling from a network share any folder structure to build your entire

library or add to any subfolder.


As stated earlier, the Admin Libraries page displays the libraries created by your organization in

PharmaReady.


To locate a library, you can sort the list by any heading. By default, only active libraries appear in

this list. To view all the libraries, clear the Active Only checkbox.


2. Click the name of the desired library.

This opens the Maintain Library page as shown below:

4.4.2 Maintain Library Page

The Maintain Library page (partially displayed in the below figure)includes two additional buttons.

We will use the Maintain Folders button in this chapter.



Figure 4.6: Maintain Library Page



3. Click the Maintain Folders button.

This displays the Folder Maintenance page as shown below.

4.4.3 Folder Maintenance Page

Figure 4.7: Folder Maintenance Page

The library’s existing directory structure is displayed on the Folder Maintenance page. If this is a

new library, you will see only the root directory.

Note : The root folder is the library itself and is created automatically by the system. All values

for the folder are defined at the library level, thus no additional data is entered here.

From this page, you can:

Add new folders and subfolders.

Modify the values of existing folders and subfolders.

Delete folders and subfolders.

4. Click the Add a Folder button to create a new folder below the folder currently highlighted in

the Library Folders hierarchy.



Figure 4.8: Folder Maintenance Page (Folder Details entered)

5. Click the Submit Folder Changes button when finished, which displays the specified folder in

the Library Folder Section of the Folder Maintenance page:

Figure 4.9: Library Folders Section

4.4.3.1 Adding Folders from a File Share (optional)

Your organization may allow you to pull existing folder structures from a network drive into a

library. When pulling folders into PharmaReady, be aware that all folders below the one you

specify are created in the library, but no documents are added.



Note : At least one network directory must be tied to PharmaReady to allow you to create

library folders from a file share.

6. Enter or select a path in the Directory field, then click the Browse button.

Note : You must enter a valid server name\share name\value before you can use the Browse

button.

7. Click the Add Folders from File Share button to create the new folder structure.

Note : You may add folders and subfolders as well as modify or delete any folder except the

root directory.

If you delete a folder, you also delete its subfolders. Any documents in the folders will

be moved to the root directory.

8. Click the Submit Folder Changes button to save the changes to the library’s directory.

9. Click the Return to Maintain Library button. The Maintain Library page displays.

10. Click the Submit button to save all changes to the library directories.

4.5 Cloning Libraries


Rather than recreating similar libraries, PharmaReady gives you the option of cloning an existing

library. When you clone a library, you copy all the data from the existing library into a new

library, including all folders and subfolders. The documents, however, are not cloned, as a

document cannot reside in more than one library.




The Admin Libraries page displays the libraries created by your organization in PharmaReady.



2. Click the name of the library you want to clone.

This opens the Maintain Library page as shown below:



4.5.2 Maintain Library Page

Figure 4.11: Maintain Library Page

The Maintain Library page looks very similar to the Add New Library page with the addition of two

new buttons. We will use the Clone Library button in this chapter.

Note : Roles and people and their relationship to libraries are covered in greater detail in the

People and Supporting Data chapter of this user guide.

3. Click the Clone Library button. A warning message appears.



The message reminds you that cloning copies the roles for this library and the people assigned to

those roles into the new library.

4. Click the OK button to perform the cloning process.

4.5.3 Maintain Library Page (clone)

Note : The Doc Auto-Num Enabled checkbox will be clear by default on a cloned library, even if

the original library used auto-numbering. This is because you cannot have two libraries

with the same Auto-Number prefix.

Caution : Remember that the Library Name and Description will include the prefix of CLONE.

Modify as desired.

5. After cloning, edit the fields from the original library before submitting the new library to

PharmaReady, as shown in the sample below:



Figure 4.12: Maintain Library Page (Details modified)



6. Click the Submit button to create the new library.

This displays the cloned library in the Admin Libraries page as shown below:

Figure 4.13: Admin Libraries Page (Cloned Library displayed)

Note : The folder structure is pulled from the original library. Follow the Build a Library

Directory procedure to add, modify, and delete folders.

4.6 Creating Categories


As stated earlier, every document must be assigned to a category in the DMS. Categories are

separate from libraries and can span libraries.

Think of a category as a document type. For example, you may establish categories for your

standard operating procedures, another for work instructions, another for policy documents, and

so on.

Like libraries, categories include auto-number and custom field functionality.

4.6.1 Admin Categories Page

The Admin Categories page displays the categories created by your organization in PharmaReady.

1. Select Admin>Categories in the DMS Home page.

The button to add a new category is located at the bottom of the Admin Categories page.



Figure 4.14: Admin Categories Page

2. Click the Add a New Category button. This opens the Add New Category page.

4.6.2 Add New Category Page

Figure 4.15: Add New Category Page

All the setup required to create a new category is performed on the Add New Category page. The

page is divided into two main sections:



Category Information

Custom Document Property Fields

Note : For easy understanding, the Add New Categorypage(Screen Shot)is separatedand

explained based on the sections specified above.

Table 4.5: Add New Category Page - Sections

Section and Description

1. Category Information

The Category Name and Description fields in this section are the only values required to save a

category to the DMS. The Category Information section is also where you set category specific

auto-numbering defaults.

3. Enter the Category details as shown in the below sample:



2. Custom Document Property Fields

You have the option of creating custom fields unique to each category in PharmaReady.

Four types of fields are available as custom fields. A category can have multiple custom fields of a

single type, and any field can be set as required.

4. Enter additional values according to the desired setup for this category, as shown in the sample

below:

3. Save Changes

5. After entering Category details and additional values according to the desired set up for this

category, click the Submit button in the Add New Category page, to save the category to

PharmaReady.

Once when the details are submitted, you are returned to Admin Categories page, which displays

the added category, as shown in the sample below:

Figure 4.16: Admin Categories Page



CHAPTER 5

5. People and Supporting Data

About this Chapter

Before users can begin managing documents in the DMS, the

users’ accounts must be established. Set up of user accounts

requires that other supporting data, such as reader groups, be

established first. In this lesson, Administrators will learn the

procedures required to set up users as well as the

recommended order of user and supporting data setup.


Contents

Topic Page

Understand the big picture of people-supporting data 69

Understand document audiences 69

Create Reader group 70

Create Reviewer group 73

Create Approver group 77

Create a site (optional) 81

Create a department 83

Create a project (optional) 85

Describe standard access roles 89

Clone and create new functional access roles 90

Create and edit people 94

5. People and Supporting Data PharmaReady™ DMS User Guide


5.1 The Big Picture of People Supporting Data

Before you begin setting up your users in PharmaReady, three other data elements must be set

up first, as this data feeds users’ accounts.

These elements—Departments, Reader Groups, and Roles—are all part of defining a user. If your

organization is using the projects functionality of PharmaReady, Projects are a fourth data

element to set up prior to entering users in the system.

Figure 5.1: People and Supporting Data

Once you’ve set up the data necessary to support users in the system, you can begin adding your

users. You have the option of adding users, called people in PharmaReady, either manually or

pulling them in from your organization’s Active Directory.

5.2 Understanding Document Audiences

To understand read access to a document in the DMS, it is important to make the distinction

between people and the audience(s) of a document. In terms of the DMS, an audience is

essentially a consumer group or groups.

The three document audiences in the DMS are:

Reader Groups

Departments

Projects

Note : While not part of system set up, read access to a document can also be granted on a

person-by-person basis.

Reader Group(s)

Department

Project(s)

Role(s)



In the example below, the glasses reflect read access. Users in both the reader group and project

can view the published document, but being a department member does not grant you access.

Figure 5.2: Read Access of User Groups

Note : Document properties are discussed in detail in the further chapters.

Audiences for a document are determined at the Document Properties level.

5.3 Create Reader Groups


When you have a group of people who share a common need to read the same documents, you

should create a reader group.

The benefit of reader groups is that read access to a document is administered at the reader

group level. In other words, you can assign a document to an entire reader group rather than on

a person-by-person basis.

Note : People can be assigned to more than one reader group.

5.3.1 Admin Reader Groups Page

The button to add a new reader group is located at the bottom of the Admin Reader Groups page.

1. Select Admin>Group>Reader Groups in the DMS Home page.

This opens the Admin Reader Groups page as shown in the figure below:

Reader Group

Project

Department



Figure 5.3: Admin Reader Groups Page

2. Click the Add a New Reader Group button, at the bottom of the page.

This opens the Add New Reader Group page as shown in the figure below:

5.3.2 Add New Reader Group Page

Creating a reader group is as simple as entering the name and a description. Once saved, the

new reader group can be assigned to any user in the system.

Figure 5.4: Add New Reader Groups Page

The Add New Reader Group page details are described in the table below:

Table 5.1: Add New Reader Groups Page – Sections



Section Instruction

Reader Group

Information

3. Enter the Reader Group and Name as shown in the sample below:

Note : If you already have users established in PharmaReady, you can

add them to the new group at this time.

Caution : Remember that no two Reader Groups can use the same

name.

Note : You can assign and edit reader group members from either the

reader group itself or on the user’s People page.

Because we are setting up your PharmaReady system, we won’t

be adding users at the reader group level. Users will be added to

reader groups later in this chapter.

Save Changes After entering Reader Group Details, click the Submit button in the Add New

Reader Groups page, to save the Reader Group to PharmaReady.



Once when the details are submitted, you are returned to Admin Reader Groups page, which

displays the added Reader Group, as shown in the sample below:

Figure 5.5: AdminReader Groups Page

5.3.3 Online Report – People by Reader Group

1. Click on the No. of Members assigned to the Reader Group (as specified in the above figure).

This displays the Report of People by Reader Group as shown in the sample below:

Figure 5.6: Online Report (People by Reader Group)

5.4 Create Reviewer Groups

When you have a group of people who share a common need to review the same documents, you

should create a reviewer group.

Note : People can be assigned to more than one reviewer group.



5.4.1 Admin Reviewer Groups Page

The button to add a new Reviewer group is located at the bottom of the Admin Reviewer Groups

page.

2. Select Admin>Group>Reviewer Groups in the DMS Home page.

This opens the Admin Reviewer Groups page as shown in the figure below:

Figure 5.7: Admin Reviewer Groups Page

3. Click the Add a New Reviewer Group button, at the bottom of the page.

This opens the Add New Reviewer Group page as shown in the figure below:

5.4.2 Add New Reviewer Group Page

Creating a reviewer group is as simple as entering the name and a description. Once saved, the

new reviewer group can be assigned to any user in the system.

Figure 5.8: Add New Reviewer Groups Page

The Add New Reviewer Group page details are described in the table below:



Table 5.2: Add New Reviewer Groups Page – Sections

Section Instruction

Reviewer

Group

Information

4. Enter the Reviewer Group and Name as shown in the sample below:



Caution : Remember that no two Reviewer Groups can use the same

name.

Note : You can assign and edit reviewer group members from either the

review group itself or on the user’s People page.


be adding users at the reviewer group level. Users will be added

to reviewer groups later in this chapter.

Save

Changes

After entering Reviewer Group Details, click the Submit button in the Add New

Reviewer Groups page, to save the Reviewer Group to PharmaReady.



Once when the details are submitted, you are returned to Admin Reviewer Groupspage, which

displays the added Reviewer Group, as shown in the sample below:

Figure 5.9: Admin Reviewer Groups Page

5.4.3 Online Report – People by Reviewer Group

1. Click on the No. of Members assigned to the Reviewer Group (as specified in the above

figure).

This displays the Report of People by Reviewer Group as shown in the sample below:

Figure 5.10: Online Report (People by Reviewer Group)

5.5 Create Approver Groups

When you have a group of people who share a common need to review the same documents, you

should create a approver group.



Note : People can be assigned to more than one approver group.

5.5.1 Admin Approver Groups Page

The button to add a new Approver group is located at the bottom of the Admin Approver Groups

page.

1. Select Admin>Group>Approver Groups in the DMS Home page.

This opens the Admin Approver Groups page as shown in the figure below:

Figure 5.11: Admin Approver Groups Page

2. Click the Add a New Approver Group button, at the bottom of the page.

This opens the Add New Approver Group page as shown in the figure below:

5.5.2 Add New Approver Group Page

Creating a approver group is as simple as entering the name and a description. Once saved, the

new approver group can be assigned to any user in the system.



Figure 5.12: Add New Approver Groups Page



The Add New Approver Group page details are described in the table below:

Table 5.3: Add New Approver Groups Page – Sections

Section Instruction

Approver

Group

Information

5. Enter the Approver Group and Name as shown in the sample below:



Caution : Remember that no two Reviewer Groups can use the same

name.

Note : You can assign and edit approver group members from either the

review group itself or on the user’s People page.


be adding users at the approver group level. Users will be added

to approver groups later in this chapter.

Save After entering Approver Group Details, click the Submit button in the Add New



Changes Approver Groups page, to save the Reviewer Group to PharmaReady.

Once when the details are submitted, you are returned to Admin Approver Groups page, which

displays the added Approver Group, as shown in the sample below:

Figure 5.13: AdminApprover Groups Page

5.5.3 Online Report – People by Approver Group

1. Click on the No. of Members assigned to the Approver Group (as specified in the above

figure).

This displays the Report of People by Approver Group as shown in the sample below:

Figure 5.14: Online Report (People by Approver Group)



5.6 Create Sites (optional)


Your organization can decide to create sites in PharmaReady to correspond to the separate

physical locations of your organization.

Use of sites is entirely optional. Sites are associated with departments. Assigning a user to a

department also associates them with that department’s site.

5.6.1 Admin Sites Page

The button to add a new Site is located at the bottom of the Admin Sites page.

1. In the PharmaReady Main Menu, Select Admin>Sites in the PharmaReady Home page.

This opens the Admin Sites page as shown in the figure below:

Figure 5.15: Admin Sites Page

2. Click the Add a New Site button, at the bottom of the page.

This opens the Add New Site page as shown in the figure below:

5.6.2 Add New Site Page

Creating a site is as simple as adding the name and a description. Once saved, the site can be

assigned to departments.



Figure 5.16: Add New Site Page

The Add New Site page details are described in the table below:

Table 5.4: Add New Site Page – Sections

Section Instruction

Site Information Enter the Site Code and Description as shown in the sample below:

Save Changes After entering Site Details, click the Submit button in the Add New Site

page, to save the Site to PharmaReady.

Once when the details are submitted, you are returned to Admin Sites page, which displays the

added Site, as shown in the sample below:

Figure 5.17: Admin Sites Page



5.7 Create Department


While optional from a system perspective, most companies set up departments in PharmaReady

that mirror the divisions of their organization. After the initial setup, departments are assigned on

a user’s account.

Two methods exist to create departments in PharmaReady:

Manually

Automatically through importing people from Active Directory (if your Active Directory

incorporates the Department field)

One of the main advantages of using departments was discussed earlier: departments define a

document audience, meaning you can assign department-level read access to a document.

When creating departments from your Active Directory, you do not use the Department pages of

the Admin menu. Instead, departments are created automatically when importing your users.

5.7.1 Admin Departments Page

The button to add a new department is located at the bottom of the Admin Departments page.

1. In the PharmaReady Main menu, select Admin>Departments in the PharmaReady Home page.

This opens the Admin Departments page as shown in the figure below:

Figure 5.18: Admin Departments Page

2. Click the Add a New Department button, at the bottom of the page.

This opens the Add New Department page as shown in the figure below:



5.7.2 Add New Department Page

Note : During initial system set up, it is likely that department managers won’t be users in the

system at the time you create their departments.

Creating a department manually is as simple as adding the department code and a description.

Once saved, the department can be assigned to any user in the system.

Figure 5.19: Add New Department Page

The Add New Department page details are described in the table below:

Table 5.5: Add New Department Page – Sections

Section Instruction

Department

Information

3. Enter the Department Code and Description as shown in the

sample below:

Note : If your organization uses sites, you may assign a site at

this time.

Save Changes 4. After entering Department Details, click the Submit button in the



Add New Department page, to save the Department to

PharmaReady.

Once when the details are submitted, you are returned to Admin Departments page, which

displays the added Department, as shown in the sample below:

Figure 5.20: Admin Departments Page

5.8 Create Project (optional)


While optional, you can set up projects in PharmaReady that mirror the projects taking place at

your organization. After their initial set up, the projects a user is working on are assigned on the

user’s account.

One of the main advantages of using projects was discussed earlier: projects define a document

audience, meaning you can assign project-level read access to a document. Documents are

assigned to projects at the document level.

5.8.1 Admin Projects Page

The button to add a new Project is located at the bottom of the Admin Projects page.

1. In the PharmaReady Main menu, select Admin>Projects in the PharmaReady Home page.

This opens the Admin Projects page as shown in the figure below:



Figure 5.21: Admin Projects Page

2. Click the Add New Project button, at the bottom of the page.

This opens the Add New Project page as shown in the figure below:

5.8.2 Add New Project Page

Note : The department reflects the primary department responsible for the project’s

management and does not assign the department’s users to the project

Project setup can include assigning a project number, a department, and people.

You can also choose to include start and stop dates to the project; these dates are informational

only and do not affect your ability to assign documents to a project. A project will remain active in

PharmaReady as long as the Active checkbox is marked.

A document can be assigned to multiple projects. Assignment occurs at the document level.



Figure 5.22: Add New Project Page

The Add New Project page details are described in the table below:

Table 5.6: Add New Project Page – Sections

Section Instruction

Project

Information

1. Enter the Project Name, Description, and Project Number.

2. Select the Department from the drop-down menu to which this project is

assigned to.

3. Select the Start Date and Stop Date of the Project.

These details are entered as shown in the sample below:

Assigned

People

Any user can be assigned to the project here; you also have the option of

assigning a user to a project via the People page.



Only those users who appear in the Assigned List box are available in the Project

Manager and Project Executive drop-down lists.

4. To add a new person to the project, click the magnifying glass ( ) and

select the user.

5. Then click the Add Person button. This displays the selected user in the

Assigned People Box as shown in the sample below:

Save

Changes

6. After entering Project Details, click the Submit button in the Add New Project

page, to save the Project toPharmaReady.

Once when the details are submitted, you are returned to the Admin Projects page, which

displays the added Project, as shown in the sample below:

Figure 5.23: Admin Projects Page



5.9 Understand Standard Access Roles

Note : The information presented here is from a set up and administration perspective.

Apart from the System Administrator role, ten standard access roles are delivered with the

PharmaReady DMS. These roles cannot be modified or deleted.

People Administrator is the one General role; it allows you to maintain people, departments, and

sites.

The remaining nine delivered roles determine functional access to documents and facilitate

document workflow. These are specified in the table below:

Table 5.7: Roles and Access Rights

Role Access Rights

Reader View documents.

Document Creator Create documents one-by-one; establish initial document properties.

Document Owner Edit document properties; update activity mode for any document for

which they are an assigned owner.

Author View documents and document properties; check out, edit, and check in

documents

NOTE: For unpublished documents, the Author role sees only documents

to which they are assigned.

Reviewer View documents and document properties, review documents.

Approver View documents and document properties, approve documents.

Publisher View documents and document properties, publish documents.

Distributor View documents and document properties, distribute documents.

Library Admin View documents, numbers, templates, and document properties; edit

document properties; upload documents; change document activity

mode; view audit log; maintain libraries, categories, reader groups,

numbers, and templates; upload and export documents in batch.



5.10 Cloning to Create New Functional Access Roles


While the general and document management roles delivered with the DMS meet the needs of

most organizations, you may find you want to create a few additional roles.

Note : To create a new role, you can either select all values manually or you can clone an

existing role. Cloning is highly recommended, as it requires only additions to an existing

role to meet your needs.

Examples of new roles you might create include:

Document Creator with Author Rights (An author who has the right to edit document

properties).

Document rights to a specified library (applicable for Owners, Creators, Authors,

Approvers, Distributors, & Publishers).

Help Desk/User Support (Department-specific general admin rights).

5.10.1 An important note about creating roles from scratch

Important : It is important to understand that the delivered roles in PharmaReady each have the

minimum rights necessary to perform associated tasks. In addition, the functional

access of each role is determined not just by marking checkboxes, but also by code

behind the scenes in PharmaReady.

For these reasons it is best not to create roles from scratch, as you may not be

granting users in these roles all the rights they need.



5.10.2 Admin Roles Page

1. In the PharmaReady DMS menu, select Admin > Roles.

This opens the Admin Roles page which contains a minimum of two tabs that logically group the

roles by purpose.

Note : You can filter by library. Keep in mind that the delivered roles will always have access

to documents in all libraries.

Figure 5.24: Admin Roles Page (DMS Tab)

Note : PharmaReady main Admin menu contains roles that are administrative in nature while

the PharmaReady DMS Admin menu contains those related to library and document

management. Each role contains the minimum library, document, and/or administrative

rights unique to the standard role.

2. Click on the name of the role you want to clone (copy) {e.g. Author}, which opens the

Maintain Role page displaying the Document Rights of this role, as shown in the below figure:



5.10.3 Maintain Roles Page

Figure 5.25: Maintain Role Page(Author Role)

Note : For delivered functional access roles, the only option you have is to clone the role. All

other fields on the Maintain Role page are grayed out and thus read only.

3. Click the Clone Role button, which displays the below warning message:

4. Click the OK button to clone this role or the Cancel button to withdraw the cloning process.

When you click the OK button, the clone name (including the prefix CLONE with an ID number), is

displayed before the Role Name and Description, as shown in the below figure:



Figure 5.26: Maintain Role Page(Edit Clone Name)

Caution : After cloning the role, you need to modify the required fields from the original role

before submitting the new role to PharmaReady.

5. Edit the Role Name and Description to ensure the purpose of the role is clear, as shown in the

below example:

6. Modify the Document Rights, as shown in the below example:



7. Click the Submit button, which creates the new Role(e.g. eCTD Sequence Administrator with

Approve Rights) and gets displayed in the eCTD Role list, as shown in the below figure:

Figure 5.27: Admin Roles Page (Cloned Role displayed)

5.11 Creating and Editing People


As stated earlier, users cannot share PharmaReady accounts. Instead, each user has a unique

Logon ID that includes personal information and defines their roles(s) in the building and lifecycle

of applications and sequences.

You can create users in PharmaReady manually, or you can import them from your organization’s

Active Directory (AD) if you have established the necessary system integration.



5.11.1 Admin People Page

1. Select Admin > People in the PharmaReady Home page.

This opens the Admin People page as shown in the figure below:

Figure 5.28: AdminPeople Page

Note : By default, the Admin People page displays the user list in a tabular format, based on

the last view during your PharmaReady session.

For example, if you click the letter “G” to view all active users whose last name starts

with that letter that view will remain when you return to the page.

Column headings displayed Admin People page, are explained below:

Table 5.8: Admin People Page (Column Headings & Description)

# Column

Heading Description

1 Active This checkbox indicates the presence of the User in the system (whether it

is currently active or not).

2 Name People Names are listed.

Click on the Name to view the details of the User.

3 Logon ID Logon ID specified for the user is displayed.

4 Department Department Name to which the user is associated is displayed.

5 Last Changed Date and Time the User details was last modified is displayed.



6 Last Logon The Last Date and Time the User has logged into the System is displayed.

Note : “Currently Active” is displayed if the Person (User) is currently

logged into the system.

7 Active Only Redisplays page with Active users(only if checked).

Tip : Click any of the column headings to sort the table by that column’s data.

Note : Before adding a user (person), you need to verify that the person does not already have

an account.

5.11.2 Add New People Page

2. Click the Add a New Person button located at the bottom of the Admin People page.

This displays the Add New People page as shown in the below figure.



Figure 5.29: Add New People Page

This page is where you assign a user to a department, define their role(s) in the system, and set

them as members of one or more document audiences.



The fields present in the Add New Peoplepage are explained in the below table:

Table 5.9: Add New People Page - Fields & Description

# Fields Description / Instruction

1 People

Information

Logon ID Enter the User ID.

First Name Enter the First Name of the User.

Last Name Enter the Last Name of the User.

Unit Enter the Unit Name (e.g. Data Management, Reg. Affairs,

etc.)

Active Active box is selected by default.

Uncheck this box, to make the User inactive.

Last Logon The Last Date and Time the User has logged into the System is

displayed when you open the Maintain People page.

Email Enter the Email ID of the User.

Phone 1 Enter the primary phone number.

Phone 2 Enter the secondary phone number.

AD

Authenticate

Check the AD Authenticate box, if your Organization is

using Active Directory (AD); otherwise, enter the User

Password Section.

AD Domain Enter the AD Domain, if you are using Active Directory.

In-place

Editing

If this person is an author and needs the ability to edit

documents checked out documents online, mark the In-

place Editing checkbox.

Keep in mind that additional setup is required on the client

workstation to fully support this functionality

Department Departments configured under Admin > Departments are

displayed in the list.

Click the drop-down menu and select the Department Name

to which the User belongs to.



Supervisor All the Users of the System are displayed.

Click the search lens icon which opens a page

displaying all the People in the System.

Select the appropriate Supervisor.

Default Printer Printers configured under Admin > System Printers are

displayed in the list.

Click the drop-down menu and select a Default Printer for

the User to print documents and reports.

2 Roles Each User must be assigned a Role.

Click the Add a New Role button, which displays a table as shown below:

Type

Click the drop-down menu, which displays all the pre-defined Role Types as

shown below:

Select the appropriate Role Type of the User.

Library

You cannot edit this field.

Department

You cannot edit this field.



Role Name

Click the drop-down menu, which displays the roles associated with the

selected Role Type (for e.g. if you select DMS under Role Type, then all the

DMS Roles are listed under Role Name):

Note : To add multiple roles, click the Add a New Role button and select

the Type and Role Name as explained above.

To delete an added role, click the Delete button, against the role.

Reader Groups Newly created Reader Groups and Imported Active Directory

Groups are displayed in the Reader Groups list.

Note: Imported Active Directory Groups is explained

under the Topic - Import People from Active

Directory.

Creation of Reader Groups and the steps to

assign a Reader Group for a person are already

explained.

Select the appropriate Reader Group displayed under

Available list.

o To assign the Reader Group from the Available list,

click the “<” directional arrow icon, to move it to the

Assigned list.

o To remove the assigned Reader Group, select the

Reader Group in the Assigned list and use the “>”

directional arrow icon to move it to the Available list.

Projects Select the appropriate Project displayed under Available



list.

o To assign the Project from the Available list, click the

“<” directional arrow icon, to move it to the Assigned

list.

o To remove the assigned Project, select the Project in

the Assigned list and use the “>” directional arrow icon

to move it to the Available list.

Job Codes These details are applicable for users associated with TRMS

module.

Specific : These fields are explained in the TRMS Help

Guide.

Job

Requirements

3 User

Password

Password Enter the password for the User to logon to the System.

Confirm

Password

Renter the same password for confirmation.

Locked Check this box, to lock the account.

4 Save

Changes

During initial set up of PharmaReady, you won’t have any document activity.

The checkboxes in the Save Changes Section can serve your users, once when

you begin managing documents.

Clear all DMS,

TRMS, and

General Action

Items for this

Person

Mark this checkbox to remove all action items from the

user’s Central page, regardless of current status.

Send Email

Notification and

create ALL

DMS Read,

Read Verify, &

Assessment

Mark this checkbox to send notification emails and to

create read, read verify, and assessment action items on

the user’s Central page. This checkbox ensures the user

moving into a role receives notification of required action

on documents.



Action Items

for this Person.

Send Email

Notification and

create ALL

TRMS Action

Items

This checkbox field is applicable for users associated with

TRMS Module.

Specific : This field is explained in the TRMS Help

Guide.

Submit Click the Submit button to save the specified information

or the Cancel button to end the function, which will not

save the changes you have entered.

When you click the Submit button, the added person gets displayed in the Admin People page as

shown in the figure below:

Figure 5.30: Admin People Page (New User added)

5.11.3 Import People from Active Directory

As stated earlier, you can create users in PharmaReady manually, or you can import them from

your organization’s Active Directory (AD) if you have established the necessary system

integration.

The steps to import people from active directory are explained below:



1. In the PharmaReady menu, select Admin > People which opens the Admin People page.

2. Click the Import People from Active Directory button.

This displays the Import People from Active Directory page as shown in the below figure:

Figure 5.31: Import People from Active Directory Page



The fields present in the Import People from Active Directorypage are explained in the below

table:

Table 5.10: Import People Page - Fields & Description

Fields Description / Instruction

1. Import People from Active Directory

a. Active Directory

Domain

The Default Domain, User Name and Password configured in

Admin > System Settings are displayed here.

b. Active Directory Logon

ID

c. Active Directory

Password

d. Groups – AD Filter This field is used to filter the Active Directory based on Groups.

e. People – AD Filter This field is used to filter the Active Directory based on People.

f. Get Available AD

Groups / People

Click the Get Available AD Groups / People button.

PharmaReady searches the Active Directory Groups and People

based on the System Integration established by your

Organization and display the Active Directory Groups and People

in the respective list box.

2. Groups and People to Import

You can import People from Active Directory in 3 different ways:

i. Import Active Directory Groups

ii. Import Active Directory People

iii. Import People from Selected Groups

i. Import Active Directory Groups

This imports the selected Active Directory Groups alone into the PharmaReady System as

Reader Groups.

g. Active Directory Groups All the Active Directory Groups are displayed in the Available list.

Select the required Active Directory Group and click the



“<”button to move the group into the Selected list.

To remove a group, select the group in the Selected list and

then click the“>” button to move the group to the Available

list.

ii. Import Active Directory People

This imports the selected Active Directory People alone into the PharmaReady System.

h. Active Directory People All the Active Directory People are displayed in the Available list.

Select the required Active Directory Person(s) and click the

“<” button to move the Person(s) into the Selected list.

To remove a Person, select the Person(s) in the Selected list

and then click the “>” button which moves the Person(s) to

the Available list.

iii. Import People from Selected Groups

This imports the People(s) from the selected Group(s) into the PharmaReady System.

i. Select People from

Selected Groups

To import people from a selected Group(s), select an Active

Directory Group(s) in the Selected List.

Click the Select People from Selected Groups button, which

automatically displays all the Active Directory People

associated with the Selected Group under Selected list.

3. Save Changes

j. Create a New

Department

Check this box if you want create a New Department, if one

is associated with a Selected Person and the Department

does not exists in PharmaReady.

k. Set all Newly Imported

Users

Check this box, if you want to set all Newly Imported users to

Authenticate against Active Directory.

l. Submit Click the Submit button, to import the Groups / People

displayed under the selected list.



5.11.4 Edit Person Details

1. In the PharmaReady menu, select Admin > People, which opens the Admin People page.

2. Click on a specific Person, which you need to edit.

This opens the Maintain People page, as shown in the figure below:

Figure 5.32: Maintain People Page (Edit People Information)



After submitting a new user to PharmaReady, additional buttons appear on the Maintain People

page.

Note : The Maintain People page allows access to reports like Access Rights Report, Activity

Report and Training Report.

Access Rights Rpt: Displays the personal information as well as the functional access

rights and document audiences of the current user.

Activity Report: Displays all document, system, and/or user activity for the current user.

Specific : Training Report is applicable for TRMS Module and is explained in TRMS Help Guide.

3. Edit the People Information fields and the Role Details as required.

4. Click the Submit button which saves the modified details and reverts to the Admin People

page.

5.11.5 Clone a Person

To create a new person, you have to select all the values manually. Cloning is recommended, as

it requires only small additions to an existing role to meet your needs.

The steps to perform a cloning process are explained below:

1. In the PharmaReady menu, select Admin > People, which opens the Admin People page.

2. Click on the name of the Person you want to clone which opens the Maintain People page.

3. Click the Clone Person button, which displays the below warning message:

4. Click the OK button to clone this Person or the Cancel button to withdraw the cloning process.

5. When you click the OK button, the clone name (including the prefix CLONE with an ID

number), is displayed before the LogonID, as shown in the below figure:



Figure 5.33: Maintain People Page(Edit Cloned Person)



Caution : After cloning the Person, you need to modify the required fields from the original Person

before submitting the new Person.

6. Edit the Logon ID, the other fields of the People Information and also the Role Details as

required.

7. Click the Submit button, which creates the new Person and gets displayed in the People list,

as shown in the below figure:

Figure 5.34: Admin People Page (Cloned Person displayed)



CHAPTER 6

6. System Maintenance and

Monitoring

About this Chapter

As an administrator in PharmaReady, understanding global and

module-specific settings and how those settings affect the rest

of the system is important. You may also need to monitor user,

system, and document activity. In this lesson, administrators

gain the knowledge required to maintain system settings and

monitor system activity.


Contents

Topic Page

Explain global and DMS-specific system settings 111

Set up system printers (optional) 120

Explain reminders (optional) 122

Monitor system activity with the Audit Log Viewer 126

6. System Maintenance & Monitoring PharmaReady™ DMS User Guide


6.1 System Settings


It is important to understand how the global and DMS values on the System Settings page affect

PharmaReady, although it is unlikely you will modify most of these values after implementation.

6.1.1 Understand System Settings Page (General)

1. Select Admin > System Settings from the PharmaReady menu.

This opens the System Settings page as shown in the figure below:



Figure 6.1: System Settings Page(General Settings)



Column headings displayed in the System Settings page are explained below:

Table 6.1: System Settings – General (Fields & Description)


1. Text Fields The first three fields on the General tab allow your organization to

create custom messages that appear on the Logon and Central pages of

PharmaReady.

a. Central

Welcome Text

You can create a custom message as Welcome Text, which will be

displayed in the PharmaReady home page

An example is provided below:

b. Central Help

Text

You can create a custom message as Central Help Text, which will

be displayed in the PharmaReady home page under Where to go for

Help Text


c. Logon Text You can create a custom message as Logon Text, which will be

displayed in the PharmaReady home page




2. Global Settings The fields in the Global Settings section determine functioning for many

areas of PharmaReady.

Note : If your organization is using Active Directory,

authentication is not handled by PharmaReady. The

Password and Number of Attempts fields are not

applicable.

The Default Printer and Action Item Validation Interval

Fields are not used during an e-CTD only implementation.

a. Password

Change

Select the number of days from the drop-down list, to set the

frequency of password changes.

b. Theme Select the required Theme from the drop-down list, for the

appearance of the application.

c. Email Alias

These 3 fields set the email account that sends and receives emails

from PharmaReady.

Specify the Email Alias, Notification and Blind CC Email.

d. Notification

Email

e. Blind CC Email

f. Number of

Attempts

This field allows you to specify the number of times a person can be

allowed to try and log into the system with an incorrect password before

the user account is locked.

Select the number of attempts from the drop-down list(0, 3, 4, 5,

or6), to set the number of incorrect logon attempts before system

lockout.

Note : If you select 0, then you are allowed to make unlimited

attempts.



g. Invalid Logon

Notify

Enter the Invalid Logon Notify email address, to alert this person

when a PharmaReady user account is locked in the system.

Note : The person will receive an email indicating the user

account is locked. An Administrator must unlock the user

account before the person gains access to the application

even with the valid password.

h. Default Printer Establishes the default printer for all Document Direct-Print icons.

Printers pre-defied (added) under Admin > System Printers are

displayed here.

Select a Default Printer from the drop-down list, for printing your

documents and reports.

Caution : If you have not selected a specific printer from My

Preferences page, then this printer will be used by

default for all the users in PharmaReady.

i. Default

Domain

These credentials are provided for Active Directory (AD) integration and

automatic resynchronization interval.

Enter the Default Domain Name, Default User Name, Default

Password and number of the days in the People Auto Update

Interval and Action items Validation Interval fields(Sets number of

days PharmaReady regenerates a user’s action item list).

j. Default User

Name

k. Default

Password

l. People Auto

Update

Interval

m. Action Items

Validation

Interval

n. Default Date

Format

Select the Default Date Format and Time format, to display

throughout the application.



o. Default Time

Format

p. Local Save

Directory

Specify the location where you need the documents to get saved.

q. Remote Save

Directory

Specify the server name and share name.

3. General E-

Signature

Settings

As an additional level of security, your organization can require users to

apply an electronic signature (e-signature) when setting up and

modifying regulatory identifiers. The meanings or reasons for the

addition or change to the regulatory identifier are added here as well.

Note : Electronic signatures can be required for specific Actions.

Check which Actions will require E-Signatures and Meaning

texts that will be presented for the specific Action.

a. Regulatory

Identifiers

This has been explained in the eCTD Module Help Guide.

The last five fields on the General tab are typically used during system setup and upgrades

only. The Send Test Email To field allows you to verify the integration with your email server by

sending a test email to any working email address. If you are using less than all four

PharmaReady modules, the Update [Module] License Key fields will activate additional modules

of PharmaReady when a valid license key is entered.

4. Test

PharmaReady

System Email

Functionality

This field is used to send the test mail for the mentioned email id in the

text box.

Enter the Test Email ID and Click the Send Test Email button to

send a Test Mail.

5. Update PR

License Key

This is used to update the PR License Number.

Enter the PR License Key and click the Update PR Key button to

update the specified license key.



6. Update DMS

License Key

This is used to update the DMS License Number.

Enter the DMS License Key and click the Update DMS Key button to

update the specified license key.

7. Update TRMS

License Key

Specific : These fields are meant for electronic Common

Technical Document and Training Management System

respectively (explained under eCTD Module - Help

Guide and TRMS Module – Help Guide).

8. Update eCTD

License Key

9. Update SPL

License Key

Specific : This field is meant for Structured Product Label

(explained under SPLModule - Help Guide).

10. Save Changes Click the Submit button to save the specified information or the

Cancel button to end the function, which will not save the changes

you have entered.



6.1.2 Understand System Settings Page (DMS)

1. In the DMS PharmaReady page, Select Admin > System Settings

This opens the System Settings page (DMS Settings), as shown in the figure below:

Figure 6.2: System Settings Page(DMS Settings)

The fields on the DMS tab establish options for all documents created in PharmaReady, regardless

of library and category. For example, you can establish an auto-numbering format for all

PharmaReady documents here. This establishes the format only; numbering options can include

auto-numbering by category and/or library as well as manual numbering.

Column headings displayed in the System Settings page(DMS Tab) are explained below:



Table 6.2: System Settings – DMS(Column Heading & Description)


1. Initial

Version

Number

Enter the Initial Version Number.

2. Doc Auto-

Num

Enabled

Only if Doc Auto Num Enabled checkbox is selected, you can enter a prefix

in the Doc Auto Num Prefix field and also specify the required number in the

Doc-Auto-Num Counter field.

3. Doc Auto-

Num Prefix

4. Doc Auto-

Num

Counter

5. Custom

Document

Property

Fields

You can also create custom fields here that will appear on the properties page

of all documents, allowing you to record standard information on every

document in PharmaReady.

Click the Add button and enter the Field Label.

Enter the prompt message in the Prompt Text box field.

Click the Delete button, to delete the specified Meaning.

Mark the Entry Required checkbox to prevent users from saving the

document properties until a value is entered in a particular custom field

An example is shown below for Text Field:



6. Save

Changes



entered.

6.2 System Printers (optional)


Establishing printers in PharmaReady first involves adding printers to the PharmaReady server

from Windows. Once the printers are established, the system administrator can add them to

PharmaReady through the System Printers menu option.

1. Select Admin>System Printers from the PharmaReady menu, to open the Admin Printers

page:

Figure 6.3: Admin Printers Page



6.2.1 Add New Printer Page

2. Click the Add a New Printer button located at the bottom of the Admin Printer page.

This displays the Add New Printer page as shown in the below figure.

Figure 6.4: Add New Printer Page

Printers added here appear as valid values in the Default Printer drop-down list on the System

Settings, People, and My Preferences pages.

Note : Only the user defined in the Default User Name field on the System Settings page can

add printers to the PharmaReady sever.

The fields present in the Add New Printer page are explained in the below table:

Table 6.3: Add New Printer Page - Fields & Description


1. Printer Information

a. Printer Name Select a printer from the list of printers defined on the

PharmaReady Server, which cannot be changed from within

PharmaReady.

b. Printer Location Enter the physical location of the printer

This is shown in the sample below:



2. Save Changes Click the Submit button to save the specified information or

the Cancel button to end the function, which will not save the

changes you have entered.

The added printer gets displayed in the Admin Printers page.

6.3 Reminders (optional)


Your organization can choose to send reminder emails to users to encourage them to take a

particular action on a document. These reminders are in addition to standard email notifications

that are triggered as part of the normal document lifecycle.

Reminders can be set at the system level, or they can be specific to documents in a library or

department.

1. In the PharmaReady DMS Home page, Select Admin >Reminders:

This opens the Admin Reminders page as shown in the figure below:

Figure 6.5: Admin RemindersPage

6.3.1 Add New Reminder Page

For each delivered reminder type, the email is sent (triggered) based on key dates defined on the

document’s properties and sent to one or more recipients based on each user’s relationship to the

document.



Set up of an email reminder includes selecting the Reminder Type, setting either the number of

days out or interval for the reminder, and writing the email subject line and message

2. Click the Add a New Reminder button located at the bottom of the Admin Reminder page.

This displays the Add New Reminder page as shown in the below figure.

Figure 6.6: Add New Reminder Page

Important : Any reminder can be sent at set intervals or a set number of days before or after a

key date. Whether the reminder is sent before or after the date that triggers it is

based on the reminder type.

A reminder can send emails at intervals or according to a set number of days before

or after a key date, but not both. A “-1” in either the Days Out to Send Reminder or

Reminder Interval Days field turns off this day/date option.

The fields present in the Add New Reminder page are explained in the below table:



Table 6.4: Add New Reminder Page - Fields & Description


1. Reminder Information

a. Reminder

Name Enter the name of the reminder

b. Description Enter a brief description about the reminder.

c. Active Active box is selected by default.

Uncheck this box, to make the reminder inactive.

d. CC Supervisor Check this box, to mark a CC to the Supervisor

e. Reminder

Type

As outlined in the table below, every reminder has set recipients and triggers.

Caution : If all of a document’s key dates needed for a particular reminder

are blank, no email will be sent.

Key dates are often date ranges defined by start and stop dates.

Reminders may be triggered before a start date or before a stop

date

When referring to the table, it is important to understand the following:

Table 6.5: Reminder Type and Trigger

Reminder Type Recipients Trigger

Approval of

Working Document

Reminder

Approvers Set number of days before the

Approval Stop Date

Document Read

Reminder

Readers Set number of days before the

Training Stop Date, else the

Effective Stop Date

Document Read

Verify Reminder

Readers Set number of days before the

Training Stop Date, else the

Effective Stop Date

Document Authors, Set number of days before



Checked-Out

Reminder

Reviewers,

Approvers

Create Stop Date, else Review

Start Date, else Approve Start

Date, else Effective Start Date,

else today’s date

Review of

Published

Document

Reminder

Authors Set number of days before the

Date Due Review date

Review of Working

Document

Reminder

Reviewers Set number of days before the

Review Stop date

Select the appropriate Reminder Type from the drop-down menu.

f. :Library Select the appropriate Library from the drop-down menu.

g. Department Select the appropriate Department from the drop-down menu.

h. Days out to

Send

Reminder

Specify the number of days out to send reminder.

i. Reminder

Interval Days

Specify the number of reminder interval days.

j. Reminder

Email Subject

The selected Reminder Type is automatically displayed here as the subject.

Edit the Subject of the Reminder Email, if required.

k. Reminder

Email

Message

Enter the Message (content) of the Reminder Email.




2. Save

Changes



entered.

The added Reminder gets displayed in the Admin Reminderspage.

6.4 Monitoring Activity with the Audit Log Viewer


6.4.1 Audit Log Viewer Page

The Audit Log Viewer page gives you a static online view of system, user, and/or document

activity in PharmaReady.

1. Select Admin > Audit Log Viewer in the DMS PharmaReady Home page.

This opens the Audit Log Viewer page as shown in the figure below:



Figure 6.7: Audit Log Viewer Page

Important : Any heading with a drop-down allows you to filter the data. For example, if you

want to see all the activity for a single document, select Document in the Type field

and enter the full document number in the Doc # field. You must click the Submit

button to update the view.

You can sort the information by any column that does not offer filtering. Simply

click the blue heading text.

6.4.2 Types and Associated Activities

The following Activity types are explained:

User Type Activities

Document Type Activities

System Type Activities



6.4.2.1 User Type Activities

The user activity visible in the Audit Log is specified in the below table:

Table 6.6: User Activities (Value and Description)

Activity Value Description

Logon Attempt Unsuccessful log on by user.

Logon Successful log on by user.

Logoff User logged off of PharmaReady manually or automatically.

Create New user created in PharmaReady.

Property Change User’s account modified, such as a password change.

Note : The Audit Log Viewer can also be launched from the Maintain People page

Click the Activity Report’s View Report button, and the Audit Log Viewer appears

filtered with user activity information for the person whose page you came from.

6.4.2.2 Document Type Activities

The document activity visible in the Audit Log is specified in the below table:

Table 6.7: Document Type Activities (Value and Description)


Create Document New document created or new version of an existing document

created

Check-In Document checked back in to PharmaReady

Check-Out Document checked out of PharmaReady

Undo Checkout Document checked out erroneously

Review Document reviewed

Approve Document approved; can include e-signature meanings



Not Approved Document not approved; can include e-signature meanings

Publish Document published; can include e-signature meanings

Print Document sent to printer

Distribute Document distributed

Property Change Document properties updated, such as removing reviewers or

changing the document title; can include e-signature meanings

View Document opened online

Verified Read Readers acknowledge reading document

Archive Document saved to alternate location, no longer accessible in

PharmaReady

6.4.2.3 System Type Activities

The system activity visible in the Audit Log is specified in the below table:

Table 6.8: System Activities (Value and Description)


Property Change System data changed, such as a change to an e-signature in

library or the addition of a reader group.

Active Directory Import Users added or updated through import from Active Directory.

Create Setup data created, such as reader groups and roles.



CHAPTER 7

7. Create Documents

About this Chapter

Document creation is the first step in the document lifecycle and

kicks off the document management workflow in the

PharmaReady DMS.


Contents

Topic Page

Understand roles and workflow 131

Create a new document 133

Create a new document using a template 151

Upload documents in batch 154

7. Create Documents PharmaReady™ DMS User Guide


7.1 Roles and Workflow

Since document workflow is fundamental to the DMS, let’s first discuss how PharmaReady roles

and workflow support the document lifecycle. Assuming all steps occur for a document—creation,

editing, review, approval, publishing, distribution, and reading—the full document lifecycle is as

follows:

Figure 7.1: DMS Life Cycle

7.1.1 DMS Roles

Each phase of the lifecycle is performed by a person in a specific role with distinct access to and

responsibility for a document. It is important to understand these roles and what each can do in

the system.

Note : Each of these roles is predefined and delivered with your installation of PharmaReady.

Your organization may create additional roles.

Table 7.1: DMS Roles and Access Rights

Role Access Rights

Document Creator Start new documents, including uploading the initial version (or

template) to PharmaReady and selecting authors, reviewers,

approvers, readers, and key dates.

Document Owner Edit document properties to facilitate workflow; publish and distribute

documents.

Author Check out, edit, and check in documents.



Reviewer Review documents.

Approver Approve documents.

Publisher Publish documents.

Distributor Distribute documents.

Reader View documents.

Library Admin Create, edit, approve, review, publish, and distribute documents for all

libraries or for a single library; create, edit, and delete libraries,

categories, document numbers, templates, and reader groups.

7.1.2 DMS Workflow

The DMS workflow merges the document lifecycle with the DMS functional access roles.

Figure 7.2: DMS Workflow



7.2 Creating New Documents

Important : This activity is performed by a Document Creator.

The PharmaReady DMS offers two different methods to create a new document in the DMS: 1)

one at a time or 2) in a batch. This section follows the procedure of creating a single new

document.

The method of document creation available to you is determined by your DMS role: Document

Creators can create single documents while Library Administrators can create singles as well as

upload multiple documents in a batch.

It is important to note that, while both the PharmaReady application and this chapter make

reference to documents, any file can technically be a document in the DMS.

1. In the PharmaReady DMS Page, Select DMS>Create Documents

This opens the Create Document page as shown in the figure below:

7.2.1 Create Document Page

Figure 7.3: Create Document



The Create Document page details are described in the table below:

Table 7.2: Create Document Page – Sections

Section Instruction

New

Document

Information

2. Select the following values from the drop-down menu, to start a new

document in the DMS.

Library

Category

Document Number

Doc Prop Template

Initial Owner

Initial Author

3. Tick the Virtual Document checkbox, if the document is uploaded from

outside of PharmaReady.

Note : When selecting a value in the Document Number field, you will see

all available auto-numbering options: system, library, and category

level as well as combinations thereof. If your organization uses

manual document numbering, all currently available numbers for

the selected category will also appear in the Document Number

drop-down list.

Note : Document templates, document properties templates, and manual

document numbers are discussed in the last lesson, Additional

Document Functionality.

Document

Source

4. Choose the template if the file is based on a template stored in the system.

5. Click the Browse button and select the appropriate file that needs to be

uploaded(added to the DMS).




Add

Document

6. Click the Submit button to save the specified information or the Cancel


entered.

Once when the details are submitted, the Document Properties page displays as shown in the

figure below:



7.2.2 Document Properties Page

Figure 7.4: Document Properties Page(General Info tab)

The Document Properties page consists of 7 tabs:

General Info

Key Dates

Authors/Owners

Reviewers

Approval

Readers

Other Prop

These details are described one-by-one below:



7.2.2.1 General Info tab

The details displayed in the General Information tab and the instructions are described below:

Table 7.3: Document Properties Page - General Info Tab


Status The current status (checked-in) of the documents displayed here.

Document Number This field is read-only; automatically displayed based on the values

selected on the Create Document page.

Document Template

Used

If the document is created using a template then the 7 for this

document is displayed in this field. A sample is shown below:

New Version Number Enter the New Version Number in this field.

Date Created The document created date is displayed here.

Last Changed The date the document underwent changes recently is displayed

here.

Changed By The role which changed the document is displayed here.

Status Report Click this button to view the Document Status.

Activity Report Click this button to open the Audit Log Viewer page where you

can view the Document Activities.

Chk In/Out Rpt Click this button to view the check-in and check-out reports.


Training Specification

Specific : This field is applicable for user associated with TRMS

Module and explained in the TRMS Help Guide.

eCTD Document



eCTD Ready to Submit

Specific : These fields are applicable for user associated with

eCTD Module and explained in the eCTD Help Guide.

Title The document title and description is pulled from the file name of the

uploaded document.

You can edit these fields as desired. Description

Author(s) This field is read-only; automatically displayed based on the values


Keywords Represents the key words used in the PharmaReady Search.

Virtual Document This field is read-only; automatically displayed based on the value

selected on the Create Document page. A tick mark represents that

the document is a virtual document.

Part of Virtual

Document

This flag represents that the document is part of Virtual Document.

Documents added under the Virtual document will be denoted as a

part of the created Virtual document as shown in the sample below:

Category This field is read-only; automatically displayed based on the value


Library This field is read-only; automatically displayed based on the value


Document Folders It is likely that you want the document to reside in one or more

folders below the root library level.

Click the Browse Folders button to access the folders in this

library.

In the Folder Browser window, expand the folders and select one

or more folders in which the document should reside (as shown in

the below sample):



Important : Within the library, be sure you store the

document in the appropriate directory using the

Browse Folders button.

The folder selected from the library’s directory

structure is where the document will be located

once it is published.

Click the Save button to save the details specified.

Activity Mode At the bottom of the page is the activity mode, which is set by default

to Edit.

It is key to select the appropriate Activity Mode radio button

based on where this new document is in its lifecycle.

For new, unpublished documents, this is typically Edit mode.

The details entered in the General Info Tab are shown in the below sample:



Save Changes Click the Submit button to save the specified information or the


you have entered.

Important : Electronic signatures (e-signatures) can be required by library for specific actions

to a document. Updating document properties is an action that can require an e-

signature and the selection of a predefined meaning behind the action.



7.2.2.2 Key Dates Tab

Figure 7.5: Document Properties Page (Key Dates Tab)

When creating a new document, you can record the key dates of its lifecycle.

Note : Most of the dates on this tab are informational, although an effective date range must be

set before the document is published.

Important : Approve End Date should not be less than Review Stop Date.

Approve Start Date should not be less than Review Start Date.

The details displayed in the Key Dates tab and the instructions are described below:

Table 7.4: Document Properties Page – Key Dates Tab

Fields Description

Create Start/Stop

Date

Tentative date range for creating/editing a document.



Review Start/Stop

Date

Tentative date range for reviewing a document. The Stop Date appears on

the Pending Doc Action report and on the Central page in the My Action

Items list.

Approve

Start/Stop Date

Tentative date range for approving a document. The Stop Date appears on

the Pending Doc Action report and on the Central page in the My Action

Items list.

Publish Date Tentative date for publishing a document. Appears on the Pending Doc

Action report.

Training Start/Stop

Date

Date range when the published document is accessible to readers for

training. These dates appear on the Published Doc Listing report.

Effective

Start/Stop Date

Date range when the published document is accessible (viewable) in the

DMS. These dates appear on the Published Doc Listing report.

Distributed Tentative date to start document distribution.

Date Due Review Future date the document should be reviewed for updates. Appears on the

Date Due Review report.

Retention

Period/End of

Retention

How long the document must be retained in the system before it may be

archived. Both values appear on the Retention Date report.

Assign the applicable dates on the Key Dates tab as mentioned above.

Note : No Dates are required to save a new document in Edit mode.



7.2.2.3 Authors / Owners tab

Figure 7.6: Document Properties Page (Authors / Owners Tab)

The initial owner and author assigned when creating the document appears on this tab by default.

If others should be allowed to check out, edit, and check in the document, move their name

to the Document Authors Assigned list.

Important : Keep in mind that all users assigned as Document Owners will receive email

notifications at each phase of the document lifecycle until the document is

published.

Caution : The initial author and owner selected when the document was created appear in the

Assigned list boxes of the Document Authors and Document Owners fields. Be sure to add authors

and owners as appropriate.

Note : The full list of email notifications by role is covered in the Chapter – ‘Edit, Review, &

Approve Documents’.

Reviewers, approvers, and readers as well as additional authors and owners can be assigned

at the time a new document is created. If not assigned initially, a person with rights to edit

document properties can assign users to these tasks after the document is saved.



7.2.2.4 Reviewers tab

On the Reviewers tab, you will add all persons assigned as reviewers. Once review activity takes

place, the event is listed in the Review Activity grid. If a reviewer has attached a file with

comments, all users who can view the document properties can open the attachment.

Figure 7.7: Document Properties Page (Reviewers Tab)

There are two options involved in Basic Cycle. Select “Sequential” for the review to take

place sequentially one after the other or Select “Parallel”, for the review to take place in any

order.

Select the Reviewers name in the Available list and click the ‘>’ icon to move the selected

reviewers name to the Assigned list box.

Select the required Document Reviewers Group in the Available list and click the ‘>’ icon to

move the selected reviewers group name to the Assigned list box.



There are three options involved in the Extended Cycle. Select “None” to use only the Basic

Review Cycle or select “Sequential” for the review to take place in sequentially, one after the

other or select “Parallel” for the review to take place in any order.

The Reviewer Activity is displayed in the grid.

7.2.2.5 Approval tab

The Approval tab includes all persons assigned to approve the document before it is published.

Approvers can be assigned in sequential order or all approvers can approve the document in

parallel. If a second round of approvals exists, you will see additional list boxes in the Extended

Cycle section with assigned and available approvers.

Figure 7.8: Document Properties Page (Approval Tab)

There are two options involved in Basic Cycle. Select “Sequential” for the approval to take

place sequentially one after the other or Select “Parallel”, for the approval to take place in

any order.



Select the Basic Approvers name in the Available list and click the ‘>’ icon to move the

selected Approvers name to the Assigned list box.

Select the required Basic Approvers Group Name in the Available list and click the ‘>’ icon to

move the selected Approvers Group name to the Assigned list box.

There are three options involved in the Extended Cycle. Select “None” to use only the Basic

Approval Cycle or select “Sequential” for the approval to take place in sequentially, one after

the other or select “Parallel” for the approval to take place in any order.

The Approval Activity is displayed in the grid.

7.2.2.6 Readers tab

Document audiences can be assigned during document creation and at any future time during the

document lifecycle, both before and after the document is published.

Figure 7.9: Document Properties Page (Readers Tab)

Click the Add a New Reader button, to specify the details of the Readers.

Note : While marked by default, the Assessment Required checkbox will trigger an action item

only if a) your organization has implemented PharmaReady TRMS and b) the document is

associated with an online test (an assessment).

By default, all read and verify checkboxes are marked for each set of readers. These checkboxes

trigger action items to appear for each person in the associated document audience.

For example, the Verify Read Required checkbox will send an action item to a single user after

they have read the document. After the user has signed off that they have indeed read the

document, the action becomes part of the document’s audit trail.



Select the Reader Type and the Reader Name from the drop-down menu.

7.2.2.7 Other Prop tab

Figure 7.10: Document Properties Page (Other Prop(erties) Tab)



Use of the Other Prop(erties) tab is at the discretion of your organization. Beyond the delivered

fields, your organization may create custom fields to hold information specific to your documents,

your industry, and so on.

The Other Prop tab includes a large selection of fields that your organization can decide to use as

part of defining a document in the DMS.

None of the standard PharmaReady fields on this tab are required to create a new document;

however, your organization may require values in one or more custom fields prior to saving.

Note : Required custom fields must contain a value before the document can be published.

The details displayed in the Other Prop(erties) tab and the instructions are described below:

Table 7.5: Document Properties Page – Other Prop Tab


Document Number,

Version and Title

The user defined fields defined in the System Settings are displayed

here.

Assessment Select the Assessment exam associated with this document.

Projects Highlight additional Projects and click the < or > buttons to add or

delete.

Product

Select the Product Name, Sponsor, Regulatory Body, and

Investigator Site from the drop-down menu.

Sponsor

Regulatory Body

Investigator Site

Subject Enter the Subject in this field.

Lot Number Enter the Lot Number.

Cabinet & Drawer Enter the Filing cabinet and drawer.

Shelf & Bin Enter the Shelf & Bin.

Disk & Filename Enter the Disk and File Name.



Reel & Frames Enter the Microfilm Reel and start and stop frame.

Image ID Specify the Imaging System unique identifier

Site Site where the document is stored.

Save Changes When the data entry is complete, Click the Submit button to save the

specified information or the Cancel button to end the function, which

will not save the changes you have entered.

Note : The file itself is housed in a SharePoint database.

Submitting the new document also triggers

PharmaReady to send email notifications to all

document owners and authors.

7.2.3 Work with Documents Page

Once when you submit the document, PharmaReady displays the Work with Documents page.

Except for readers, all roles can now see the new document here.

Figure 7.11: Work with Documents Page



7.2.3.1 A few key items on the Work with Documents Page:

Filtering options is available to select a Library and Folder, where in the user can select a

specific Library and choose Browse folder to view the documents in the selected Library and

Folder. This is shown in the sample below:

Figure 7.12: Work with Documents Page (using filtering options)

Also filtering options is available under the Document List to view the documents based on the

Statuses under different categories.

The document title is an active hyperlink that will open the document online without checking

it out.

To add the document to the Quick View section of your Central page, mark the QV checkbox.

The users can perform only those activities for which they are assigned access. For example,

the users who are assigned as “Readers” can only read the document and they cannot

approve unless they are provided access.

The documents for which the user had been assigned any kind of access will only get

displayed in the Document List.



7.3 Creating a New Document using a Template

(optional)

Important : This activity is performed by a Document Creator.

If your organization uses standard templates to provide consistent formatting and structure to

your documents, those templates can be housed in PharmaReady.

When it comes time to create a new document in the DMS, you have the option of selecting one

of the templates previously loaded by an administrator. As a document creator, you create the

new document as you would any other document, but rather than pulling an external file into the

DMS, you select the pre-loaded template from a list.

Note : Except selecting a template, the remaining steps of creating a document using a

template are the same as the previous procedure, Creating a New Document.

1. Select DMS> Create Documents from the DMS PharmaReady Home Page. The Create

Documents page displays.

2. Select the library and category for the document.

3. Select a numbering format for the document.

4. Select the Initial Owner and Author of the document.

5. Select from the Template drop-down list to attach the predefined template.




Figure 7.13: Create Document Page

6. Click the Submit button to save the document to PharmaReady. The Document Properties

page displays:



Figure 7.14: Document Properties Page

7. Update the Document Title, if desired, and add a Description and Key Words.

8. Using the Browse Folders button, select the appropriate folder.

9. Update the Activity Mode, if appropriate.

10. On the Key Dates tab, assign applicable dates.

11. On the Authors/Owners, Reviewers, and Approvers tabs, assign people according to their

respective role and relationship to this document.

12. On the Readers tab, click the Add a New Reader button. Select each applicable document

audience and unmark any unnecessary action checkboxes.

13. On the Other Prop tab, add document data according to your organization’s needs.

14. Click the Submit button to save the document properties to PharmaReady.



7.4 Upload Documents in a Batch

Important : This activity is performed by a Library Administrator.

Library administrators can upload multiple documents to the DMS in a single batch. This method

of rapid creation (or publishing) works well when you have documents that share common

information. For all documents uploaded in a batch, the documents must have the following in

common:

Library

Category

Auto-numbering format

Initial Author and Owner

Activity Mode, either Edit (for new documents) or Publish

Root Network Directory (but not necessarily subfolders)

Custom field values (if required)

Published documents uploaded in a batch should also have the following in common:

Readers

Published Version Number

Publish Format (same PDF options or original document format)

Effective Dates

Note : To reduce data entry errors and save time, consider using a document properties

template when uploading published documents in a batch. Document properties

templates are covered in detail in the Additional Document Functionality chapter.



7.4.1 Batch Upload Page

All the steps required to upload a set of new or published documents in a batch are performed on

the Batch Upload page.

1. Select DMS> Batch Upload from the PharmaReady DMS Page.

This displays the Batch Upload page as shown in the figure below:

Figure 7.15: Batch Upload Page

The page is divided into functional sections:

i. Batch Upload Document Information

ii. Source Documents

iii. Set Mode

iv. Publish Options (for published documents only)

v. Upload Options



These details are explained in the table below:

Table 7.6: Batch Upload Page Details


1. Batch Upload Document Information

Information in this section populates much of the General Information tab of the Document

Properties for each uploaded document. Note that each upload has a unique batch number and

that you must provide a Batch Description. All documents will have the same person as the

initial author; additional authors can be added later.

Batch Number This field is automatically displayed. However you can edit the

Batch Number.

Batch Description Enter a valid and a brief description about the batch.

Library Select the appropriate Library and Category for the documents,

from the drop-down menu. Category

Auto Document

Number

Select an auto-numbering format for the documents, from the

drop-down menu.

The option Manual Number is included in the Document Number

field. The User can upload the Batch with Manual Numbers, if the

Manual Number option is selected.

Doc Prop Template Choose the appropriate Document Property Template from the

drop-down menu.

Initial Owner Select the Initial Owner and Author from the drop-down menu, for

all the documents. Initial Author

Create Virtual

Document

Tick this checkbox, if you wish to create a virtual document

(outside of PharmaReady).

Create Selected Folders

for Selected Files

Tick this checkbox, if you wish to create Selected Folders for

Selected Files.



These details are specified as shown in the sample below:

2. Source Documents

The directory you enter in this section must have an established connection with PharmaReady.

This connection is typically established during implementation.

In the Enter Starting Directory field, enter the server name and the network path where

the documents are located.

Note : If documents live in separate folders below a certain level, enter the highest level

directory.

Click the Show Files button to display the folder structure of the path you entered.

Expand folders and check the appropriate files, from different paths for upload.




3. Set Mode

As stated earlier, you can batch upload a set of new documents that will initially be in the Edit

Activity Mode, or you can upload a set of Published documents.

When uploading published documents, you must enter at least one set of readers.

Select the Activity Mode, either Edit or Publish.



4. Publish Options

Note : Each publishing option is covered in detail in the Publish, Distribute, and Read

Documents chapter.

For published documents only, complete the Publish Options section to indicate the version

number of all published documents, the document’s published format, and associated dates.

Update the Effective Dates if applicable.

Note : Note that the Effective Date fields automatically populate with today’s date and one

year from today. You can change these values here. You can also change them per

document after the files are uploaded to the DMS.

5. Upload Action

Click the Submit button to upload the selected documents into the PharmaReady System or

the Cancel button to end the function, which will not save the changes you have entered.

Note : If the documents will be formatted as PDFs, it may take a few moments for the

documents to appear as published in PharmaReady.

6. Batch Upload Report

After the batch is submitted and processed, the system automatically generates a Batch Upload

Report and displays it in the current browser window.

Review the Batch Upload Report to ensure all files uploaded successfully.



Figure 7.16: Reports Page



CHAPTER 8

8. Edit, Review & Approve

Documents

About this Chapter

The key lifecycle stages of unpublished documents include

authoring, review, and approval. In this chapter, we will take a

document through the pre-publishing steps of its lifecycle.

This chapter is important for persons in the Author, Reviewer,

Approver, and Document Owner roles, as it discusses when they

become involved in the workflow of a document and the related

procedural steps.


Contents

Topic Page

Understand document statuses 162

Understand Workflow Navigation 163

Email Notifications and Workflow 165

Check out a document 166

Check in a document 171

Update a document’s activity mode 175

Review a document 178

Approve a document 184

8. Edit, Review and Approve Documents PharmaReady™ DMS User Guide


8.1 Document Statuses

When a document is first created in the DMS, it is in a Checked-In status. As it moves through its

lifecycle, a document can have many statuses; these are defined in the table below.

Notice that, for any given role, functional access to a document is according to its status.

Table 8.1: Functional access to a document

Status Role Definition

Checked In Authors The document is available for checkout and editing by an

Author. It could also mean the document is ready for review

but not yet moved to the next status (* Refer the note below).

Checked Out Authors The document is currently checked out by an Author.

Reviewing Reviewers The document is in the review process. It could be awaiting

review or being reviewed.

Reviewed Reviewers The document is reviewed but not yet moved to the next status

(* Refer the note below).

Approving Approvers The document is in the approval process. It could be awaiting

approvals, or not approved

Approved Approvers The document is approved but not yet moved to the next

status(* Refer the note below).

Pending Publishers The document is available to be published or is in the process

of being published and converted to PDF.

Published Distributors

Readers

The document is now published and visible to all document

audiences with view rights.

* Note :Document Owners are responsible for updating the activity mode of a document. Doing so

updates the document’s status and makes it accessible to the next role.

Note : Note that “distributed” is not a status. A document can be distributed many times, but it

remains in a Published status.



8.1.1 Document Status, Roles, & the DMS Workflow

The DMS Workflow is once again displayed below:

Figure 8.1: Document Status, Roles, & the DMS Workflow

8.2 Workflow Navigation

Both the Work with Documents page and the Central page offer functional access to pages where

you complete required actions according to your role.


On the Work with Documents page, the following icons appear for documents depending on your

role and pending action.

Table 8.2: Work with Documents Page icons and functions

Icon Visible to Indicates Function

Authors Available for

check out

Click to access the Check Out a Document page.

Authors Checked out Click to access the Check In a Document page.



Reviewers Ready for

review

Click to open the document in a new browser

window. The current window displays the Review a

Document page.

Approvers Ready for

approval

Click to open the document in a new browser

window. The current window displays the Approve a

Document page.

Publishers Ready for

publishing

Click to access the Publish a Document page.

Distributors Ready for

distribution

Click to access the Distribute a Document page.

8.2.2 DMS Central Page

On the DMS Central page, two separate sections offer functional access to workflow items.

First, the My DMS Quick View List includes the same icons as the Work with Documents page.

Keep in mind that you must add documents to the Quick View before they appear on the Central

page.

The other section of the DMS Central page is the DMS Action Items tab. This section displays all

action items triggered by system and user events. For example, when a document moves into a

new activity mode, the update triggers PharmaReady to send the appropriate user(s) an action

item.

Note : If you are set up to receive email notifications, you will receive an email indicating when

an action is required of you. The email will include a hyperlink that launches the

appropriate page for the required action.



Figure 8.2: Central Page

8.3 Email Notifications and Workflow

At the beginning and end of each phase of the document lifecycle, an email goes out to the

appropriate party notifying them of required or completed actions.

Below are the types of emails users receive according to their role and assignment to a

document. This is shown in the table below:

Table 8.3: Role and Email Notification

Role Email Notification

Authors New Document Notification

Document Returned to Edit Mode Notification

Document Owners New Document Notification



Document Reviews Completed Notification (can include Review

Summary report)

Document Approval Completed Notification (can include Document

Approval History report)

Document Not Approved Notification (can include Document

Approval History report)

Reviewers Document Review Notification (can include CheckIn/Out Summary

report)

Approvers Document Approval Notification

Readers Document Distribution Notification

Important : It is important to note that three roles do not receive email notifications:

Document Creators, Publishers, and Distributors.

If your organization uses the Publisher and Distributor role, they should be

contacted by the Document Owner when the document is ready to publish and

distribute.

8.4 Checking out Documents

Important : This activity is performed by the Author.

When a new document is created with you as the author, you will receive a “New Document

Notification” email. From this point, you are able to check out the document (or template) and

work in the file. Depending on your implementation of PharmaReady, you may work online or

save the file to a directory prior to beginning your work.

It is a good idea to check the QV (Quick View) checkbox for documents you work with frequently.

Marking this checkbox adds the document to your Central page as a Quick View list item.

A document must be in the Edit Activity Mode to be available to an author for check out.

In this procedure, we begin by navigating to the Work with Documents page and locating the

document. While the “New Document Notification” email does contain a hyperlink to the

document, the link launches the file without actually checking it out for editing.



Note : Checking out a document changes the Status on the Document Properties page to

Checked Out.


For authors, the default settings on the Work with Documents page display all the unpublished

documents you are currently working on. You can filter the view by library, library folders,

category, and status.

1. Select DMS>Work with Docs from the PharmaReady DMS page.

The Work with Documents page displays as shown below:


2. Locate the document you want to check out and click the Check Out ( ) icon.

Note : While a document can have multiple authors, only one author at a time can check out a

document.



8.4.2 Check Out a Document Page

The Check Out a Document page provides read-only document information. You can click the

right arrow button next to the Document Information section heading to display key document

dates.

Figure 8.4: Check Out a Document Page

3. Click the Submit button to check the document out of PharmaReady.

8.4.2.1 Editing Location

Depending on your workstation configuration, user settings, and implementation of PharmaReady,

authors can edit documents in one of two locations:

Online, called “in-place editing”.

From a directory where the file was saved, either local or a network file share.

Note : Hosted clients do not have the option of in-place editing.



Note : The In-place editing checkbox on the Maintain People page determines whether

documents are opened in a browser window or must be saved before editing.

With in-place editing, the document is opened in a Web browser and edited entirely online.

Without in-place editing, you save the checked out file to a directory of your choosing, then work

in its respective application.

If your organization allows for in-place editing, authors can still elect whether to use it. Contact

your system administrator if you want to use in-place editing, as it requires a local plug-in as well

as turning on the functionality for your PharmaReady user account.

8.4.3 In-Place Editing (Non-Hosted Clients)

With in-place editing, a new Web page opens when you submit the check out request. The page is

initially blank; you must click the Edit button to display the file and begin editing.

Click the Edit button. The document appears below.

Figure 8.5: Edit Document



When you have finished editing, click the Save & Exit button.

Caution : Don’t forget to save to your work frequently.

8.4.3.1 A few words about in-place editing:

Important :

Do not use the Open or Save menu options from the File menu.

Once you have checked out the document, no other author can access or edit the file until

you check it back in.

You should save frequently. If your PharmaReady session times out, the work since the last

save is lost.

You do not need to check the document back in each time you end your PharmaReady

session. To access a document you have checked out at any time, click the file name on the

Work with Documents page.

8.4.4 Saving the Document

Without in-place editing, after clicking Submit you will be asked whether you want to open the file

or save it. You should save the file to a directory. Once saved, you can open and edit the file

using its respective application.

Important : If nothing happens after clicking Submit, it is likely that your browser is blocking

pop-ups. You must change your browser settings to allow pop-ups from the

PharmaReady URL.

Figure 8.6: File Download



Click the Save button.

Figure 8.7: Check Out a Document Page

The File name automatically appears in the following format:

[DocNumber]__[DateStamp]__[TimeStamp].[extension].

Select the desired directory and save your file. You can now open and work in the file using its

respective application.

8.5 Checking in Documents

Important : This activity is performed by the Author.

When you have completed your desired edits to a document, the next step is to check the

document back in to the DMS.

Electronic signatures (e-signatures) can be required by library for specific actions to a document.

It is likely that checking in a document is an action that requires an e-signature and the selection

of a predefined meaning behind the action.

System Administrators can check in documents at any time.

In this procedure, we begin on the Work with Documents page.

Note : Checking in a document changes the Status on the Document Properties page to Checked

In.




For authors, the default settings on the Work with Documents page display all the unpublished

documents you are currently working on. You can filter the view by library, library folder,

category, and status.

1. Select DMS>Work with Docs from the PharmaReady DMS Home Page.

The Work with Documents page displays.

From the Work with Documents page, all authors assigned to the document can see who has it

checked out. Hold your cursor over the Checked Out text in the Status column to display the

hover text.

This is displayed in the figure below:


2. Locate the document you want to check-in, Click the Check In ( ) icon.

This displays Check In a Document page as shown below:



Figure 8.9: Check In a Document Page

8.5.2 Check In a Document Page

The Check In a Document page allows you to:

i. Select and upload the edited file (for authors not using in-place editing)

ii. Check in the editing file (for authors using in-place editing)

iii. Upload a different file (regardless of an author’s editing functionality)

iv. Abandon changes and release the original file to the DMS

To upload a different file, click the Add button and navigate to the file to be checked in.

This page may also include e-signature fields. For documents requiring a check-in e-signature,

select a Meaning and enter your Password.

You also have the option of making comments in the Change Summary text box regarding this

round of editing.

This is shown in the figure below:



Figure 8.10: Check In a Document Page(Change Summary entered)

When a document is ready for the next stage in its lifecycle, a document author must contact the

Document Owner and request the change in activity mode.

Note : If you accidentally checked out the document and are not uploading an edited file, use

the Abandon Changes button.

3. After updating the details, click the Submit button.

You will return to the Work with Documents Page.


When edits are made to a file, the previous versions are visible on the Work with Documents

page. Each time a document is checked out, edited, and checked back in, the version number is

increased by one.



3. Click the expand icon (right arrow button) adjacent to the document to view the previous

versions.

This is shown in the figure below:

Figure 8.11: Work with Documents Page(previous versions viewed)

8.6 Updating Activity Mode

Important : This activity is performed by the Document Owner.

When a document is ready to move in the workflow (either forward or back for editing), one of

the Document Owners assigned to the document must access the Document Properties page and

update the activity mode.

The Document Owner can update the document to any activity mode.

We will follow a basic document lifecycle and move the document forward for review.

8.6.1 Work with Document Page

On the Work with Documents page, Document Owners can see every document in the library or

libraries to which they are assigned.

1. Select DMS>Work with Docs in the PharmaReady Home page.



Note : The Author must alert the Document Owner when the document is ready to move to

review mode.

Tip : To quickly locate a document, select its library, folder (using the Browse Folders button),

and category.


2. Locate the document you want to update and click the View Properties icon.

This displays the Document Properties page.



8.6.2 Document Properties Page

Figure 8.13: Document Properties Page

3. Select the appropriate Activity Mode radio button appearing at the bottom of the General Info

tab of the Document Properties page.

For example, if you want make the document available to Reviewers, select the Review radio

button as shown in the sample below:



Additional information may be required at the time you update the activity mode. For example,

you will need to provide a new version number value if the document creator did not do so.

4. Click the Submit button, in the Document

This displays the Work with Documents page.

8.6.2.1 About Updating the Activity Mode

Here are a few items to keep in mind when updating activity mode:

As the PharmaReady DMS is delivered, Document Owners, Library Administrators, and

System Administrators can update a document’s properties.

The Description, New Version Number, and Effective Dates fields all become required fields

as the document moves through its lifecycle. If this data is not added at the time a

document is created, you will be prompted to add required values as part of updating the

activity mode.

You can make multiple changes to the Document Properties page during the same session.

For example, you can add a Reviewer to the document properties, then move it to Review

mode. Once in review mode, however, you cannot add people as Reviewers.

8.7 Reviewing Documents

Important : Performed by one or more Reviewers. May also be performed by a delegated

Reviewer as established on the My Preferences page.

Once a document is ready for review and placed in the Review activity mode by a Document

Owner, the assigned Reviewers receive an email notification and an action item.

As a Reviewer, you can open the document in a browser window and review it online or you

can print a hard copy. You cannot, however, make any edits to the source document. Instead,

you are able to attach an edited copy of the document (or any other attachment) to your

review.



You can see the comments of any previous reviews, and if the review has an attachment, you

can open and add to it.

After all reviews are in, all Document Owners receive a “Document Reviews Completed

Notification” email. If any of the reviews require that changes to the file, the document must

be returned to the Edit activity mode.


Note : You can access documents awaiting your review from the Work with Documents page;

each will be marked with a Review icon.

The best way to conduct a review is to use both active hyperlinks for the review item on the

Central page.

o First, you’ll access the file from the Title hyperlink, either saving a copy or opening it

online.

o After reviewing it, you’ll return to the Central page and click the Review hyperlink.

1. Select DMS>Central from the PharmaReady DMS page.

The DMS Central page displays:


2. Click the document name in the Title column.



8.7.2 Opening/Saving the Document

When conducting a review, you have the option of viewing the document online or saving it to a

directory of your choosing. If you want to markup the document and/or access it apart from

PharmaReady, you should elect to save it to a directory.

Note : If you are using Firefox, a similar pop-up box appears. With either Internet Explorer or

Firefox, you have the option of turning off this pop-up by selecting one option (open or

save) for all instances.

3. Click the Save button.





4. Select the desired directory and save your file. You can now open and work in the file using its

respective application.

You can now review your file at your discretion.


After reviewing the document, you should return to the Central page to complete the process.

1. Select View>Central from the PharmaReady DMS page.




2. Click the Review hyperlink in the Action column. The File Download window appears again, as

shown in the below sample:

3. Click the Cancel button. The Review a Document page will appear.



8.7.4 Review a Document Page

Figure 8.16: Review a Document Page

The Review a Document page allows you to enter a small number of comments as well as attach

a file. The file you attach is visible to all of the document’s Reviewers as well as the Document

Owner(s).

4. Enter your review comments and attach a file (if desired).

The details are entered as shown in the sample below:



Note : For documents requiring an e-signature, select a meaning and enter your password on the

Review a Document page.

5. Click the Submit button.

You will return to the DMS Central page.

8.8 Approving Documents

Important : Performed by one or more Approvers. May also be performed by a delegated

Approver as established on the My Preferences page.

Note : Before updating the activity mode, direct the class to the Reviewers tab and point out the

comments and attached files (if any). Then return them to the General Info tab and

update the activity mode to Approve before proceeding.

Once all reviews are in and a Document Owner has updated the activity mode of the document to

Approve, assigned Approvers receive an email notification and action item. If the approvals are

set as sequential, only the first Approver will receive notification. After their approval, the next

Approver in line will receive their notification and action item.

Electronic signatures (e-signatures) can be required by library for specific actions to a document.

It is likely that approving a document is an action that will require an e-signature and the

selection of a predefined meaning behind the action.




The best way to conduct a review is to use both active hyperlinks for the approve item on the

DMS Central page.

First, you’ll access the file from the Title hyperlink, either saving a copy or opening it

online.

After reviewing it, you’ll return to the DMS Central page and click the Approve hyperlink.

Note : You can access documents awaiting your approval from the Work with Documents page;

each will be marked with an Approve icon.

1. Select View>Central in the PharmaReady Home page.

This displays the DMS Central page:


2. Click the document name in the Title column.



8.8.2 Opening/Saving the Document

When approving a document, you have the option of viewing the document online or saving it to

a directory of your choosing.

Note : If you are using Firefox, a similar pop-up box appears. With either Internet Explorer or

Firefox, you have the option of turning off this pop-up by selecting one option (open or

save) for all instances.

3. Click the Save button.



4. Select the desired directory and save your file. You can now open and read the file outside of

the browser.



8.8.3 Central Page

After reviewing the document, you should return to the DMS Central page to complete the

process.

1. Select DMS>Central in the PharmaReady Home page.


2. Click the Approve hyperlink in the Action column.

The Approve a Document page will appear.

8.8.4 Approve a Document Page



Figure 8.19: Approve a Document Page

The Approve a Document page allows you to approve or not approve the file.

Note : The fields on this page can also generate an e-signature by requiring a meaning and your

password to approve (or not approve) the document. The meaning you select should

correspond to whether you approve or do not approve.

6. Enter your approval comments(if desired) as shown in the sample below:

Note : If you are not approving the document, click the Not Approved button.

7. Click the Approved button.

You will return to the DMS Central page.

Note : Once all approvals are completed, the author receives a “Document Approval Completed

Notification” email to announce that the document is ready for publishing.



CHAPTER 9

9. Publish, Distribute & Read

Documents

About this Chapter

The final steps in the document’s lifecycle include the publishing

of documents, the distribution of documents and associated

reader notification(s), and the actions required of the readers

themselves.


Contents

Topic Page

Publish a document 190

Distribute a document 196

Read a document 198

Verify reading a document 200

Locate documents at every lifecycle stage 201

9. Publishing Documents PharmaReady™ DMS User Guide


9.1 Publishing Documents

Important : Performed by a Publisher or Document Owner assigned to the individual

document.

Once the activity mode of a document is set to Publish, the document is ready to become live in

the DMS. Publishing a document changes who can view the document.

For example, readers can see published documents in the DMS that are in effect and to which

they have read rights.


Documents in the Publish activity mode that have yet to be published show a status of Pending on

the Work with Documents page.

Caution : All documents waiting to be published are in a Pending status; this includes documents

that are added to the DMS in the Publish Activity Mode initially. In other words, a

publisher must perform this step on all documents in the DMS. Documents that are

published as part of a batch upload are the exception.

1. Select DMS>Work with Docs in the DMS Home page.


2. Locate the document you want to publish, and click the Publish ( ) icon.



9.1.2 Publish a Document Page

Figure 9.2: Publish a Document Page

The Publish a Document page is divided into sections:

i. Document Information

ii. Approval Activity

iii. Publish Options

iv. Save Changes

The Publish a Document page details are described in the table below:



Table 9.1: Publish a Document Page – Sections

Fields - Description &Instruction

1 & 2. Document Information& Approval Activity

The first two sections of the Publish a Document page provide read-only information related to the

document, key dates (if you expand the Document Information section heading), and approvals.

Caution : If a document is assigned to a library that requires approvals prior to publishing, the

Submit button will not appear on the Publish a Document page until all approvals are

complete. A warning will also appear at the top of the page. Remember that the

document must be returned to the Approval Activity Mode to complete this step of the

workflow.



3. Publish Options

a. Format In the Publish Options section, you should select the format and, if publishing in PDF

format, the specific settings for the published document.

Three formats exist for publishing a document:

In original format—will not PDF the file and no formatting or security settings will

be applied.

In original PDF format and apply PDF options— use when the original file is a PDF

and you want to add formatting and/or establish security.

In PDF format and apply PDF options—use to convert a file to a PDF and add

formatting and/or establish security.

Note : PharmaReady can convert the following file types to PDF: .doc,

.docx, .ppt, .pptx, .xls, .xlsx, .rtf, .rtfx.

b. PDF

Options

The table below details the formatting applied by each PDF format checkbox.

Table 9.2: Publish a Document Page (PDF Options)


Include the

Following text as a

Watermark

Applies the text entered in the adjacent field as a

watermark on each page of the published document.

Include version

and published

Date watermark

Applies the version number and date the document was

published as a watermark on each page of the published

document.

Create Bookmarks

from Style Settings

(for Word Docs)

Creates hyperlinks in the PDF file based on predefined

styles from Microsoft Word.

Append Document

Control

information page

Adds a final page to the published document providing

Document Control data (doc #, version, library, author,

key dates, and reader rights).

Prevent PDF from Allows readers to view the document, but disables printing



being Printed options.

Prevent PDF

contents from

being Copied or

Saved as another

Format

Allows readers to view the document, but disables copy

and save options in Adobe Acrobat.

Include Printed

Date in Document

Date appears on printed document

Select the required PDF options.

c. Training

Dates

The training date fields add to and can overlap the effective dates. Let’s say a

document will become effective one month from now. If this month is slated for

training, your training dates can reflect that. From a system perspective, the

training dates ensure that readers can see the document during the training

phase.

d. Effective

Dates

The effective date range defaults to one year starting from today’s date unless

overridden by a document properties template. You can modify the effective date

range accordingly. Training dates are optional.

e. Training

Document

Specific : These fields are explained in the TRMS Help Guide.

f. Expire

Previous

Versions

The Expire Previous Versions checkbox is immediate. In other words, the

previous version of the document will no longer be visible to readers once the

new version is published. If the effective dates of the new version are out in time,

then a period of time will exist when neither version is visible.

If you uncheck the Expire Previous Versions checkbox and future date a new

version of a document, then the old version will be expired on the date the new

version becomes effective (assuming the previous version does not expire before

that date).

Details are entered as shown in the sample below:



4. Save Changes

e-signature If your organization requires an e-signature for publishing, select the meaning

(reason) for the publish action and enter your password.

Each library can have e-signatures required as part of publishing a document. If

an e-signature is required, you will be asked for your password and to assign a

predefined meaning each time you publish a document.

Submit After entering the details, click the Submit button.



9.2 Distributing Documents

Important : Performed by a Distributor or Document Owner assigned to the individual

document.

Once a document is published, readers must be notified that the document is now available.

Distributing a document triggers action items and email notifications, so this step is vital in terms

of communication and assigning the appropriate reader actions.

As stated earlier, the final status of an effective document is Published. Distributed is not a

status. A document can be distributed many times, but its status will not change until it expires,

is expired, or is archived.


On the Work with Documents page, Distributors and Document Owners will see all published

documents in the libraries to which they have rights. Keep in mind you may need to update the

Status filter on the page to Published.

1. Select DMS>Work with Docs from the DMS Home Page.


2. Locate the document you want to distribute and click the Distribute ( ) icon.



9.2.2 Distribute a Document Page

The Distribute a Document page provides a view of document information as well as document

readers and their current status. The page also serves to launch action items and notifications to

readers based on the values selected here.

The first time you distribute a document, it is likely you will distribute it using the All Readers

radio button in the Quick Select Readers section. You also have the option of notifying Authors,

Approvers, Reviewers, and Publishers.

At any time, you have the option of selecting specific readers individually or based on their status.

3. On the Distribute a Document page, select the desired distribution options and enter a

comment for your readers, as shown in the sample below:

Figure 9.4: Distribute a Document Page



4. After specifying the required details, click the submit button.

You will return to the Central page.

9.3 Reading Required Documents

Note : As soon as a document is published, readers can see it on the Browse Documents page.

The events that occur for readers upon distribution of a document are determined by two pages in

PharmaReady. Who receives a distribution notification is determined by the settings on the

Distribute a Document page. Whether the reader has required actions associated with a document

is determined by checkboxes on the Readers tab of the Document Properties page.

When a document is distributed, every reader that has elected to receive email notifications from

PharmaReady receives a “Document Distribution Notification” email.

A distribution notification lets you know that the document is available for you to read. If you are

required to read the document, you will receive a Read action item on your Central page when

the document is distributed or when an administrator sends DMS action items to you by updating

your Maintain People page.

9.3.1 Central Page

1. Select DMS>Central in the DMS Home page.

Note : The Due Date for each read action is the Effective Stop Date from the Document

Properties’ Key Dates tab.



Figure 9.5: DMS Central Page (Action – Read)

2. Click the Read hyperlink in the Action column.

Note : If nothing happens after clicking the hyperlink, it is likely that your browser is blocking

pop-ups. You must change your browser settings to allow pop-ups from the PharmaReady

URL.

9.3.2 Reading a Document

When you click either the Read hyperlink on the Action Item or the hyperlink from the notification

email, the document opens in a browser window. Closing the browser window indicates to

PharmaReady that you have read the document and clears the Read action item from the Central

page.

3. After reading the document, close the browser window.



9.4 Verifying Reading a Document

If you are required to verify that you have read a document, this is a separate action from

reading the document. As such, readers receive a separate action item that appears after opening

the document or clicking the Read hyperlink.

The Verify Read action does not have a corresponding email notification since the action item

appears immediately after reading the document.

9.4.1 Central Page

Closing the document’s browser window triggers PharmaReady to create the Verify Read action

item.

1. Select DMS >Central in the DMS Home page.

Figure 9.6: Central Page (Action – Verify Read)

2. Click the Verify Read hyperlink in the Action column.

This displays the Verify Read page.

9.4.2 Verify Read Page

The Verify Read page is a second level of assurance that a reader has indeed read a document.

Depending on library settings, this step can also include use of e-signatures. In this case, readers

are asked for their password and to assign a meaning to the action before they can submit the

page.



3. If an e-signature is required, select a meaning and enter your password in the Verify Read

Action section.

Figure 9.7: Verify Read Page

4. Click the Submit button.

You will return to the Central page.

9.5 Locating Documents

As PharmaReady DMS users, you should now be familiar with locating documents using the

PharmaReady menu and filtering views by fields such as Library, Category, and Status.

Beyond the menu, the DMS offers two other means of locating documents:

o The Browse Documents page

o The Search page



9.5.1 Browse Documents Page

The Browse Documents page displays all published documents in their respective library folder

structure. Since Readers do not have access rights to published documents on the Work with

Documents page, this is their primary means of accessing all their documents in a library.

1. Select DMS>Browse Docs in the DMS Home Page.

This displays the Browse Documents page.

2. To locate a document, expand the appropriate folders in the library where the document is

published.


Figure 9.8: Browse Documents Page

Note : If your implementation of PharmaReady allows you to print directly from the application,

a printer icon appears adjacent to each document. Note that hosted clients do not have

printing capability from PharmaReady.

From this page, you can print, read, and verify that you have read documents. You also have the

option of saving documents to the Quick View section of the Central page.



9.5.2 The Search Page

For DMS users, the Search page provides a robust tool for locating any document to which the

user has rights.

1. Click Srch from the set of common page buttons to access the Search page.

This displays the Search page as shown below:

Figure 9.9: Search Page

The Search page is divided into two tabs: Criteria and Results.

The Search instructions are explained below:



9.5.2.1 Criteria Tab

Note : Readers will not see documents that are not in effect.

Table 9.3: Search Page

Fields - Description &Instruction

1. Criteria Tab

This tab includes all available search fields.

Create New To create a new search, enter a name in the field adjacent to the Create New

button, then click Create New.

Saved Searches To use a saved search, select it from the drop-down list and click the Load

button.

Text Contains You can perform a Text Contains search from any page using the Srch field.

Enter the text you want to search by and click the Srch button adjacent to the

field.

The Results tab of the Search page will automatically display all current

documents containing that text.

Quick Meta

Search

You can search key fields including; Title, Doc Number, Keywords and the

Custom Properties fields displayed below.

Library

Select the Library, Category, Status, Project, Department, Job Requirement

and Assessment from the drop-down list.

Category

Status

Project

Department

Job Requirement

Assessment



Doc. Number

Enter the Doc. Number and Title.

Title

Keywords Enter the Keywords in this field.

Effective Only Notice that the Effective Only checkbox on the Criteria tab is always on by

default. This ensures the results include current documents only.

Turn off this Effective Only checkbox to search for all documents regardless of

when they are in effect.

2. Results Tab

Once you click Search, you are automatically taken to your list of results.

From here you can access document properties, view the document itself, print, and add

documents to your Quick View list:

Figure 9.10: Search Page (Results Tab)

Return Click the Return button to return to the Central Page.



CHAPTER 10

10. Different Types of Reports

All delivered reports pertaining to documents, people, and

monitoring system activity are accessed from the Reports

menu. This chapter includes the following sections:

Contents

Topic Page

Archive Report 207

Batch Export Report 208

Batch Upload Report 209

Date Due Review 210

Delegated Approvals 211

Doc Approve History 212

Doc Chk InOut Sum 213

Doc Folder List 214

Doc Review History 215

Doc Workflow Assign 216

Pending Doc Action 217

People Wrkflw Assign 218

Pub Doc by Readers 219

Published Doc List 220

Read Verify Summary 221

Access Report 223

Delegation Report 224

Read Verify Activity 224

Reader Summary 225

Required Reading 227

Retention Date 228

Audit Log Listing 229

Access Rights 230

Data Summary 231

People by Department 232

People by Project 233

10. Different Types of Reports PharmaReady™ DMS User Guide


10.1 Archive Report

1. Select Reports > Archive Report in the DMS Home Page.

This displays the screen shown below:

Figure 10.1: Archive Report (View Report)

Tip : Click the button to show / hide the parameters.

2. Select the required value from the Archive Number drop-down menu and click the View Report

button.

This displays the Archive Report based on the selected value, as shown in the sample below:

Figure 10.2: Archive Report

3. Click the Close button to close this report and view another report.



10.2 Batch Export Report

1. Select Reports >Batch Export Report in the DMS Home Page.


Figure 10.3: Batch Export Report (View Report)

2. Select the required value from the Batch Number drop-down menu and click the View Report

button.

This displays the Batch Export Report based on the selected value, as shown in the sample below:

Figure 10.4: Batch Export Report




10.3 Batch Upload Report

1. Select Reports > Batch Upload Report in the DMS Home Page.


Figure 10.5: Batch Upload Report (View Report)

2. Select the required value from the Batch Number drop-down menu and click the View Report

button.

This displays the Batch Upload Report based on the selected value, as shown in the sample

below:

Figure 10.6: Batch Export Report




10.4 Date Due Review Report

1. Select Reports >Date Due Review Report in the DMS Home Page.


Figure 10.7: Date Due Review Report (View Report)

2. Enter the due Review Begin Date

3. Enter the Due Review end Date.

4. Select the required Library from the drop-down menu.

5. Enter the Training or Effective On Date and click the View Report button.

This displays the Date Due Review Report based on the selected value, as shown in the sample

below:

Figure 10.8: Date Due Review Report




10.5 Delegated Approvals Report

1. Select Reports >Delegated Approvals Report in the DMS Home Page.


Figure 10.9: Delegated Approvals Report (View Report)

2. Select the Document Number, Delegated By (role), and Delegate To (role) from the drop-

down menu.

3. Select the Approved On Begin Date and End Date from the date-picker icon and click the View

Report button.

Note: The Approved On Begin Date & End Dates are only if NULL option is deselected.

This displays the Delegated Approvals Report based on the selected value, as shown in the

sample below:



Figure 10.10: Delegated Approvals


10.6 Doc Approve History Report

1. Select Reports >Doc Approve History Report in the DMS Home Page.


Figure 10.11: Doc Approve History Report (View Report)

2. Select the required Library, Category and Document Number from the drop-down menu and

click the View Report button.

This displays the Doc Approve History Report based on the selected value, as shown in the

sample below:



Figure 10.12: Doc Approval History


10.7 Doc Check In Out Sum

1. Select Reports >Doc Check In Out Sum Report in the DMS Home Page.


Figure 10.13: Doc Check In Out Sum (View Report)

2. Select the required value from the Document Number drop-down menu and click the View

Report button.

This displays the Doc Check In Out Sum Report based on the selected value, as shown in the

sample below:



Figure 10.14: Doc Check In Out Sum


10.8 Doc Folder List Report

1. Select Reports >Doc Folder List Report in the DMS Home Page..


Figure 10.15: Doc Folder List Report (View Report)

2. Select the required Library and Category from the drop-down menu and click the View Report

button.

This displays the Doc Folder List Report based on the selected value, as shown in the sample

below:



Figure 10.16: Doc Folder List Report


10.9 Doc Review History Report

1. Select Reports >Doc Review History Report in the DMS Home Page.


Figure 10.17: Doc Review History Report (View Report)

2. Select the Library, Category and Document Number from the drop-down menu and then click

the View Report button.

This displays the Doc Review History Report based on the selected value, as shown in the sample

below:



Figure 10.18: Doc Review History Report


10.10 Doc Workflow Assign

1. Select Reports > Doc Workflow Assign Report in the DMS Home Page.


Figure 10.19: Doc Workflow Assign Report (View Report)

2. Select the required Library, Document Number from the drop-down menu and click the View

Report button.

This displays the Doc Workflow Assign Report based on the selected value, as shown in the

sample below:



Figure 10.20: Doc Workflow Assign Report


10.11 Pending Doc Action

1. Select Reports >Pending Doc Action Report in the DMS Home Page.


Figure 10.21: Pending Doc Action (View Report)

2. Select the Library and Limit Report By from the drop-down menu.

3. Enter the Begin Date and End Date and then click the View Report button.

This displays the Pending Doc Action Report based on the selected value, as shown in the sample

below:



Figure 10.22: Pending Document Action Report


10.12 People Workflow Assign

1. Select Reports >People Workflow Assign Report in the DMS Home Page.


Figure 10.23: People Workflow Assign Report (View Report)

2. Select the required Library and Person from the drop-down menu and click the View Report

button.

This displays the People Workflow Assign Report based on the selected value, as shown in the

sample below:



Figure 10.24: People Workflow Assign Report


10.13 Pub Doc by Readers

1. Select Reports >Pub Doc by Readers Report in the DMS Home Page.


Figure 10.25: Pub Doc by Readers (View Report)

2. Select the Library, Category, Person, Reader Group, Department, Project, and Job Code from

the drop-down menu.

3. Enter the Training or Effective On Date and then click the View Report button



This displays the Pub Doc by Readers Report based on the selected value, as shown in the sample

below:

Figure 10.26: Published Document Listing by Readers (View Report)


10.14 Published Doc List

1. Select Reports >Published Doc List Report in the DMS Home Page.


Figure 10.27: Published Doc List (View Report)

2. Select the Library, Category from the drop-down menu



3. Enter the Training or Effective on date and then click the View Report button.

This displays the Published Doc List Report based on the selected value, as shown in the sample

below:

Figure 10.28: Published Document Listing Report


10.15 Read Verify Summary

1. Select Reports >Read Verify Summary Report in the DMS Home Page.


Figure 10.29: Read Verify Summary (View Report)

2. Enter the Date Format, Time Format.



3. Select the Person, Library, Category, Reader Group, Project, Department, Supervisor, and

Show Only Docs Not Verify Read from the drop-down menu and then click the View Report

button.

This displays the Read Verify Summary Report based on the selected value, as shown in the

sample below:

Figure 10.30: Read Verify Summary




10.16 Access Report

1. Select Reports >Access Report in the DMS Home Page.


Figure 10.31: Access Report(View Report)

2. Select the Role and Library from the drop-down menu and click the View Report button.

This displays the Access Report based on the selected value, as shown in the sample below:

Figure 10.32: Access Report




10.17 Delegation Report

1. Select Reports >Delegation Report in the DMS Home Page.


Figure 10.33: Delegation Report (View Report)

2. Select the Delegate Type from the drop-down menu and click the View Report button.

This displays the Delegation Report based on the selected value, as shown in the sample below:

Figure 10.34: Delegation Report


10.18 Read Verify Activity

1. Select Reports >Read Verify Activity Report in the DMS Home Page..




Figure 10.35: Read Verify Activity (View Report)

2. Select the Library, Category, and Person from the drop-down menu.

3. Enter the Document Number in the Doc # field and then click the View Report button.

This displays the Read Verify Activity Report based on the selected value, as shown in the sample

below:

Figure 10.36: Read Verify Activity Report


10.19 Reader Summary

1. Select Reports >Reader Summary Report in the DMS Home Page.




Figure 10.37: Reader Summary (View Report)

2. Select the Department and Supervisor from the drop-down menu and click the View Report

button.

This displays the Reader Summary Report based on the selected value, as shown in the sample

below:

Figure 10.38: Read Summary Report




10.20 Required Reading Report

1. Select Reports >Required Reading Report in the DMS Home Page.


Figure 10.39: Required Reading Report (View Report)

2. Select the required Person from the drop-down menu and click the View Report button.

This displays the Required Reading Report based on the selected value, as shown in the sample

below:

Figure 10.40: Required Reading Report




10.21 Retention Date

1. Select Reports >Retention Date Report in the DMS Home Page.


Figure 10.41: Retention Date Report (View Report)

2. Enter the Retention Begin Date, Retention End Date.

3. Select the Library from the drop-down menu and then click the View Report button.

This displays the Retention Date Report based on the selected value, as shown in the sample

below:

Figure 10.42: Retention Date Report




10.22 Audit Log Listing

1. Select Reports >Audit Log Listing Report in the DMS Home Page.


Figure 10.43: Audit Log Listing (View Report)

2. Enter the Begin Date, End Date.

3. Select the Person, Document Number, Activity, Sort Order and Report Type from the drop-

down menu.

This displays the Audit Log Listing Report based on the selected value, as shown in the sample

below:

Figure 10.44: Audit Log Listing Report




10.23 Access Rights Report

1. Select Reports >Access Rights in the DMS Home Page.


Figure 10.45: Access Rights Report (View Report)

2. Select the Person from the drop-down menu

3. Select the appropriate option (True or False) in the Show Detail and then click the View Report

button.

This displays the Access Rights Report based on the selected value, as shown in the sample

below:

Figure 10.46: Access Rights Report




10.24 Data Summary Report

1. Select Reports >Data Summary Report in the DMS Home Page.

This displays the PharmaReady Data Summary Report shown below:

Figure 10.47: Data Summary Report (View Report)




10.25 People by Department

1. Select Reports >People by Department Report in the DMS Home Page.


Figure 10.48: People by Department (View Report)

2. Select the Department and Supervisor from the drop-down menu and click the View Report

button.

This displays the People by Department Report based on the selected value, as shown in the

sample below:

Figure 10.49: People by Department




10.26 People by Project

1. Select Reports >People by Project Report in the DMS Home Page.


Figure 10.50: People by Project (View Report)

2. Select the Project, Department, and Supervisor from the drop-down menu.

3. Enter the Project Effective on Date and then click the View Report button.

This displays the People by Project Report based on the selected value, as shown in the sample

below:

Figure 10.51: People by Project




CHAPTER 11

11. Additional Document

Functionality

About this Chapter

Additional document functionality exists in the PharmaReady

DMS system that can speed document creation and ensure

consistency across documents. This functionality includes the

ability to predefine both document templates and sets of

document properties as well as to create document numbers

manually. Use of this functionality is at the discretion of your

organization.


Contents

Topic Page

Archive Documents 235

Create document numbers manually 237

Create document templates 241

Create document properties templates 245

11. Additional Document Functionality PharmaReady™ DMS User Guide


11.1 Archive Documents

1. Select DMS > Archive Docs in the PharmaReady DMS Home Page.

This displays the figure shown below:

Figure 11.1: Archive Documents

2. Select the Archive Number

3. Enter the Archive Description

4. Select the appropriate Library from the drop-down menu

5. Select the Activity Mode from the drop-down menu

6. Click the Browse button and select the appropriate directory where the documents need to be

archived.

This displays the list of documents shown in the sample below:

7. Select the required documents from the list and then click the Submit button

This displays the Archive Report, as shown in the sample below:



Figure 11.2: Archive Report

11.2 Creating Document Numbers Manually

Important : This activity is performed by the Library Administrator.

Every document in the DMS must have a unique document number. How you number your

documents is up to your organization.

PharmaReady offers the document numbering options as shown in the table below:

Table 11.1: Document Numbering Options

Automatic

Numbering

Document numbers are created by the system during document creation.

The Document Creator selects a predefined format and the system

automatically assigns the next available number based on the selected

format. Automatic numbering can be set at the system, library, and

category level.

Manual

Number

Creation

Document numbers are created before and are initially separate from the

documents themselves. Library Administrators create these custom

numbers in any format your organization desires. Document Creators can

see these manually created numbers on the Doc Number Manager page.



If your organization wants to use legacy numbers or another document numbering format apart

from the delivered automatic numbering functionality of PharmaReady, then the Library Admin

must create these document numbers.

A few key points to remember when creating document numbers manually:

The PharmaReady DMS does not require you to choose one numbering system at the

exclusion of the other.

Manual numbers can be category specific.

Manual numbers are created one at a time.

You cannot use manually created numbers when uploading documents in a batch.

Manual numbers can only be created by a Library or System Administrator.

11.2.1 Doc Number Manager Page

Whether created manually or generated by the system, every document number in the DMS can

be seen on the Doc Number Manager page. For Library Administrators, this page displays a

button allowing you to create new document numbers manually.

1. Select DMS>Doc Numbers in the DMS PharmaReady Home page.

Figure 11.3: Doc Number Manager Page



2. Click the Add a New Doc Number button. This displays Add a New Doc Number page:

11.2.2 Add a New Document Number Page

Figure 11.4: Add a New Doc Number Page

The fields displayed in Add a New Doc Number page are explained in the table below:

All entry required to create a new document number occurs on this page.

Table 11.2: Add a New Doc Number Page – Fields

Section Instruction

Category Select the required Category from the drop-down menu, which is optional.

Number Enter the Document number in this field.

Note : Use your Organization’s Document Number Format.

Title Enter a Title for the Document Number.

Owner Enter an Owner for the Document Number.

Status When creating new document numbers, you select the status of the number as

Issued or Reserved.

Issued -These document numbers are immediately available for use.

Reserved - These document numbers are on hold and cannot be assigned. A



Library Administrator must update the number’s status before it can be used

to create a new document.

Super ceded

by

Enter the Document Numbers that super cede this Document Number.

The details entered in the Add a New Doc Number page are shown in the sample below:

Save

Changes

Click the Submit button to save the new document number to PharmaReady.

Once when the details are submitted, you are returned to Doc Number Manager page, which

displays the added Document Number, as shown in the sample below:



Figure 11.5: Doc Number Manager Page

11.3 Creating Document Templates


Your organization most likely uses templates to ensure consistent formatting, graphics, sections,

and the like, in files of the same type. You can easily add these templates to PharmaReady.

For example, all of your Standard Operating Procedures have the same title page, headers,

footers, fonts, etc., and this information is stored in a template. You have the option in

PharmaReady to load your SOP template into the system so that when it’s time to create a new

SOP, your organization’s custom template serves as the basis for starting a new document.

When a document is created in the DMS using a template, the author will check out and fill in the

template as part of the editing activity of the document lifecycle.

A few key things about document templates in the DMS:

Any type of file can be uploaded as a document template, not just application-specific

template files (such as a .dot file).

Document templates are not version controlled.

Document templates can be library specific.



11.3.1 Doc Template Manager Page

The button to add a new document template is located at the bottom of the Doc Template

Manager page.

1. Select DMS>Doc Templates in the DMS PharmaReady Home page.

Figure 11.6: Doc Template Manager Page

Note : Select All in the Library field to make the template accessible when creating documents

in any library.

2. Click the Add a New Document Template button.

This displays the Add a New Doc Template page:

11.3.2 Add a New Document Template Page

Figure 11.7: Add a New Doc Template Page



Creating a new document template in PharmaReady involves associating the template with one or

all libraries, giving the template a title that allows it to be easily recognized in the DMS, and

uploading the template file itself.

The fields displayed in Add a New Doc Template page are explained in the table below:

Table 11.3: Add a New Doc Template Page – Fields

Section Instruction

Active This checkbox is enabled by default to represent the Doc Template is

currently active.

You can uncheck this box, if you want to make the Doc Template

inactive.

Library Select a Library, enter a Title,

Note : Selecting All in the Library field makes the template

available in every library.

Title

The name of the template file will populate the Title field when a

document is created from a template. The Document Creator can edit

this value before submitting the new document to the DMS

Classification Enter the Classification of the Template.

Uploaded File Check the Overwrite box if you want to overwrite any existing uploaded

template file. Overwrite

Template File Click the Browse button and upload the desired template file from your

workstation or network.

The details entered in the Add a New Doc Template page are shown in the sample below:



Save

Changes

Click the Submit button to save the new document template to the

PharmaReady.

Once when the details are submitted, you are returned to Doc Template Manager page, which

displays the added Document Template, as shown in the sample below:

Figure 11.8: Doc Template Manager Page (added template displayed)



11.4 Creating Document Properties Templates


It is likely that your organization will have documents that share common document properties.

For example, you may have a department that develops and follows a set of SOPs. The reviewers,

approvers, and readers of those SOPs are the same, and the length of retention before a required

review is part of your company policy. Creating a template for these common properties can

speed entry of your SOPs in the DMS.

When uploading documents in a batch, using a document properties template will save you from

having to enter information for multiple documents manually.

11.4.1 Admin Doc Prop Templates Page

The Admin Doc Prop Templates page includes a button for creating new document properties

templates.

1. Select Admin>Doc Prop Templates in the DMS Home page.

This displays the Admin Doc Prop Templates page as shown below:

Figure 11.9: Admin Doc Prop Templates Page

2. Click the Add New Document Properties Template button.



11.4.2 Add New Doc Prop Template Page

Figure 11.10: Add New Doc Prop Template Page

The tabs and fields on the Add New Doc Prop Template page mirror the fields on the Document

Properties page.

The Add New Document Properties Template page consists of 7 tabs:

General Info

Key Dates

Authors/Owners

Reviewers

Approval

Readers

Other Prop

These details are described one-by-one below:



11.4.2.1 General Info tab

The details displayed in the General Information tab and the instructions are described below:

Table 11.4: Add New Document Prop Template Page - General Info Tab


Enter the default values that you want to appear as document properties when creating new

documents based on this properties template.

Template Name Enter the Template Name in this field.

Important : The Template Name entered on this tab should

be descriptive enough that Document Creators

understand which type of document these

properties should populate.

Category Select the appropriate Category of this Template.

Select the appropriate Library of this Template.

Active By default this field is checked.

Uncheck this box, if you want to make this Doc Prop Template

inactive.


Training Specification

Specific : This field is applicable for user associated with TRMS

Module and explained in the TRMS Help Guide.

eCTD Document

Specific : These fields are applicable for user associated with eCTD

Module and explained in the eCTD Help Guide.

eCTD Ready to Submit

Title Enter the Title and Description in the respective fields.



Description

Keywords Represents the key words used in the PharmaReady Search.

Activity Mode At the bottom of the page is the activity mode, which is set by default

to Edit.

It is key to select the appropriate Activity Mode radio button

based on where this new document is in its lifecycle.

For new, unpublished documents, this is typically Edit mode.

The details entered in the General Info Tab are shown in the below sample:

Save Changes Click the Submit button to save the specified information or the


you have entered.



11.4.2.1.1 About the Activity Mode:

Important : Remember that the Activity Mode determines where a document is in its

lifecycle and which role has access to it.

For new documents, the default of Edit is the likely choice.

For legacy documents published elsewhere that you are bringing into the DMS, however,

you may change the Activity Mode to Publish.

11.4.2.2 Key Dates tab

Note : The dates on this tab are discussed in detail in Chapter 5 – Create Documents > Creating

New Documents >Document Properties page, which is a prerequisite for this chapter.

You have the option of setting numeric values in key date fields that are then used to

calculate the respective date when the properties template is applied.

For example, let’s say a new document should be edited and ready for review in 60 days. You

would set the Create Start Date value to 0 days (reflects the date the template was applied)

and the Create Stop Date value to 60 days.

All the fields on this tab are optional when setting up a document properties template. To not

apply a date, enter or leave “-999” in the field.



Figure 11.11: Add New Doc Prop Template Page(Key Dates Tab)

11.4.2.3 Authors / Owners tab

Select the Document Author(s) from the available list and move it to the Assigned list.

Select the Document Owner(s) from the available list and move it to the Assigned list.

Figure 11.12: Add New Doc Prop Template Page(Authors / Owners Tab)



11.4.2.4 Reviewers tab

Select the Document Reviewer(s) from the available list and move it to the Assigned list.

Figure 11.13: Add New Doc Prop Template Page (Reviewers Tab)



11.4.2.5 Approval tab

The Approval tab allows you to set a sequence for approvers and, if desired, to create a second

approval cycle.

Select the Document Approver(s) from the available list and move it to the Assigned list.

Figure 11.14: Add New Doc Prop Template Page (Approval Tab)



11.4.2.6 Readers tab

The Readers tab allows you to set the default document audience(s) for published documents

based on this document properties template. You can select one or more reader groups,

departments, projects, or people on this tab and which actions are required of each audience.

Select the Reader Type and the Reader Name from the drop-down list as shown in the sample

below:

Figure 11.15: Add New Doc Prop Template Page (Readers Tab)

Note : Once saved to the DMS, you have the option of cloning Document Properties Template.



11.4.2.7 Other Prop tab

Finally, the Other Prop(erties) tab includes fields such as Project that can be common to multiple

documents. Also, if your organization has defined custom fields at the system or library level,

adding the values here saves data entry time when the template is applied.

Figure 11.16: Add New Doc Prop Template Page (Other Prop Tab)



The details displayed in the Other Prop(erties) tab and the instructions are described below:

Table 11.5: Add New Document Prop Template Page – Other Prop Tab


Assessment Select the Assessment exam associated with this document.

Projects Highlight additional Projects and click the< or > buttons to add or

delete.

Product

Select the Product Name, Program, Sponsor, Regulatory Body,

and Investigator Site from the drop-down menu.

Program

Sponsor

Regulatory Body

Investigator Site

Subject Enter the Subject in this field.

Lot Number Enter the Lot Number.

Cabinet & Drawer Enter the Filing cabinet and drawer.

Shelf & Bin Enter the Shelf & Bin.

Disk & Filename Enter the Disk and File Name.

Reel & Frames Enter the Microfilm Reel and start and stop frame.

Image ID Specify the Imaging System unique identifier

Site Site where the document is stored.

Save Changes When the data entry is complete, Click the Submit button to save

the new document properties template to PharmaReadyor the


you have entered.

Once when you submit the document, the added Doc Prop Template is displayed in the Admin

Doc Prop Template page.



11.4.3 Admin Doc Prop Template Page

Figure 11.17: Admin Doc Prop Templates Page



12. Appendix

12.1 Glossary

Term Description

Access Rights A specific functional permission that is associated with a Role.

Action A specific activity related to a Document. Actions include Check Out,

Check In, Review, Approve, Publish, and Distribute.

Activity Mode A Document Property that defines what Actions can be performed on a

Document.

Approve Mode A Document Activity Mode that allows Approvers to approve Documents

for Publishing and post comments related to their approval.

Archive Mode A Document Activity Mode that flags Documents for archiving.

Author A User who is authorized to Check Out and Check In a Document.

Authors also maintain Document properties and manage a Document’s

Activity Mode.

Category A defined set of terms that can be associated with a Document.

Document A specific file-based item that is managed by PharmaReady™.

Documents can be any MS Office file or related element (Visio drawing,

JPEG, etc.)

Document

Number

A document management device used to track the life cycle of a specific

document. For example, a SOP may be initially assigned a document

number of SOP.001.

Edit Mode A Document Activity Mode that allows Authors to Check Out a Document

for editing and Check In Edited versions of Documents.

Effective Period The time between the Effective Start Date and the Effective Stop Date

where a Published Document is available for access to authorized Users.

Effective Start

Date

The date on which a Published document is available for access by

Readers.

Effective Stop The date after which a Published document is restricted from access to

12. Appendix PharmaReady™ DMS User Guide


Date Readers.

Folder A hierarchical structure for storing Documents. A Folder is associated

with only one Library. Within Libraries, Documents can be associated

with one or more Folders.

Library A defined grouping of related Documents. A Document can reside in only

one Library.

Owner A person responsible for the contents of any Document published using a

Document Number.

PDF Adobe’s Portable Document Format standard for creating read-only

versions of Documents.

Publish Mode A Document Activity Mode that allows Publishers to perform publishing

actions on a Document.

Review Mode A Document Activity Mode that allows Reviewers to access read-only

versions of Documents and post comments to the Author about those

versions.

Role A defined set of functional access rights that be assigned to a User.

Version A snapshot of a document that is retained in PharmaReady™. Point

versions (i.e. 2.1, 2.2) are produced while a document is in an edit cycle,

are discarded after the document is published.

User A person who has been authorized to use the PharmaReady™ system and

been given personal logon credentials.