firstdoc overview

Solution Presentation

Dr. Reddy‘s Lab

May 25th, 2011

04/09/23 CH10_0373 2© 2010 Computer Sciences Corporation

CSC Company Overview

Since 1959, We’ve Helped Clients Achieve Competitive Advantage from Every Major Technology Wave

We are a world leader in leveraging IT to develop business solutions and services

Market-leading corporations and major government agencies partner with us when delivery is critical to their mission

Our 91,000 professionals serve clients in more than 90 countries

We have a 50-year track record of client service excellence

Our global delivery network provides consistent delivery of solutions and services ― common processes and highly skilled, cost-effective, multilingual resources

We are CSC: an NYSE, Fortune 200 and Fortune “Most Admired Company” ― 50 Years Strong

Across the globe ― when delivery is critical


CSC ECM Business Strategy

• CSC developed products that continue to enhance and grow to meet customer needs

• Professional services to drive value of the products into customer specific solutions

• Continued extensions of product and services capabilities

Domain Expertise

C O M B I N E

T OC R E A T E

C U S T O M E R L O N G E V I T Y

• CSC industry knowledge and expertise in focused industries

• Content management/ collaboration

Platform Expertise• Documentum• Microsoft

Product Strategy• FirstDoc (Documentum)• FirstPoint (SharePoint)

Professional Services• Tightly aligned with product and

platform strategy• Implementation, upgrades, and

system integration with products• Integration with products and

data stores• ECM CMA services• Microsoft SharePoint services

CSC Company Overview

Product Overview

Franciska DarmerSolution Specialist


FirstDoc Enterprise Content Management Solution

• Industry’s leading Life Sciences content management solution geared towards the authoring, review, approval, storage and retrieval of an organization’s mission critical documents

• FirstDoc Enterprise Platform based on EMC Documentum

• 21 CFR Part 11 Compliant

• Out of the box, preconfigured modules for Life Sciences business areas:– Research and Development (R&D)– Trial Master File (TMF) (next generation FDCT)– Quality and Manufacturing (Q&M)– Marketing and Sales (M&S)

• Other areas available via configuration:– Medical Information– Human Resources– Legal

FirstDoc Overview


SharePoint Portal

FirstDoc WebTop or SharePoint Portal

BusinessRules Engine

Key Features

Compliance

Document Template

Notification

Workflow

Document Lifecycle

Search

Automation

Reporting

Watermarking

Administrative Tools

Personalization

Business-Specific Configurations

PDF Management and Publishing

InternalUser Interface

InternalStakeholders

ExternalUser Interface

ExternalStakeholders Regulatory Agencies Customers Supply Chain Business Partners

R&D TMF Q&M Sales & Marketing

Corporate

Content Management

EMC Documentum

FirstDoc Architecture — Designed to Meet Specific Business Needs


FirstDoc Enterprise + Best Practice Modules

APPLICATION INTEGRATIONS

Research & Development Quality Manufacturing Trial Master Files Marketing and Sales Medical Information Corporate

• eCTD publishing tools• FDX Connector• Paper publishing tools• Registration tracking

• ERP systems• Learning management

tools

• Clinical trial management systems

• Imaging tools• FD IA connector• FD PDF Publisher• FD Export

• Siebel sales• Seibel marketing

• Siebel call center• XML authoring tools• Xml publishing tools

• ERP systems• Accounting• Engineering

drawing tools

BEST PRACTICE MODULES

Research & Development Quality Manufacturing Trial Master Files Marketing and Sales Medical Information Corporate

• All submission-related document types

• Non-clinical, clinical, quality, regulatory

• Document types according to eCTD

• SPL labeling documents

• Procedural documents• CMC documents• Validation documents• Batch record documents• Package artwork• Package specifications

• Clinical• Clinical site• Clinical subject• CRFs/DCFs

• Promotional and Collateral materials

• Letters• Components• Whitepapers and

journals• Open, body, close,

attachments

• Legal– Contracts– Pleading

documents– Patent

documents– SEC filings– Research

documents• Engineering

– Engineering drawings

SHARED FUNCTIONAL CAPABILITIES

Functional Capabilities Lifecycle & Workflow Management

Compliance Compound Documents Innovative Utility and Tools

• Template-based authoring• Auto-filing of documents• Copy properties and

documents• Register interest/

notifications• MyViews• Data dictionaries• Dynamic security• Restricted property edit

• Document auto-numbering

• Document and folder purge

• User bulk import• Auto-populating of

properties• Product, compound, and

study dictionaries• Compound alias tracking• Local language capable

• Dynamic workflow• Email notifications• Automatic status transition• Batch status transition

• Document audit trails

• eSignature and watermarking

• Document information reporting

• Audit trail reporting

• XML document importing

• Compound document templates and authoring

• Multi-document routing and review

• Multi-document status update

• Configuration management utility

• Batch import• User/group

administration• Configuration objects

FirstDoc Overview


Key Items in the FDQM Configuration Set

• Properties, Search Screens, Views

• Lifecycles– Controlled Document– Reports– Records

• Workflows– Review– Approval – with Electronic Signatures– Periodic Review– Change Request– To Be Read and Understood

• Notifications

• Relationships

• Watermarks, Headers, Footers

• Auto-numbering

• User Groups and Security

• Document Purging

FirstDoc Product Details


Document Inventory Analysis

Released Document•Specifications & Methods•Standard Operating Procedures•etc.

Standard Document•Validation Documents•Project Documents•etc.

FirstDoc 6.2

THANK YOU

firstdoc overview

Documents

compound document templates

regulatory document

business solutions

services capabilities

multidocument routing

firstdoc architecture

life sciences business

properties product