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Configuration Instruction

SIMATIC PCS 7 – SIMATIC IT – Integration SIMATIC PCS 7 / SIMATIC IT Integration Pack 2007

Electronic Signature in SIMATIC IT Production Suite

Warranty, liability and support

Electronic Signature in SIMATIC PRS 26639558

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NOTE The application examples are not binding and do not claim to be com-plete regarding the circuits shown, equipping and any eventuality. The application examples do not represent customer-specific solutions. They are only intended to provide support for typical applications. You are responsible in ensuring that the de-scribed products are correctly used. These application examples do not relieve you of the responsibility in safely and professionally using, installing, operating and servicing equipment. When using these application examples, you recognize that Siemens cannot be made liable for any damage/claims beyond the liability clause described. We reserve the right to make changes to these application examples at any time without prior notice. If there are any deviations between the recommendations provided in these application examples and other Siemens publications - e.g. Catalogs - then the contents of the other documents have priority.

Warranty, liability and support We do not accept any liability for the information contained in this document.

Any claims against us - based on whatever legal reason - resulting from the use of the examples, information, programs, engineering and performance data etc., described in this application example shall be excluded. Such an exclusion shall not apply in the case of mandatory liability, e.g. under the German Product Liability Act (“Produkthaftungsgesetz”), in case of intent, gross negligence, or injury of life, body or health, guarantee for the quality of a product, fraudulent concealment of a deficiency or breach of a condition which goes to the root of the contract (“wesentliche Vertragspflichten”). However, claims arising from a breach of a condition which goes to the root of the contract shall be limited to the foreseeable damage which is intrinsic to the contract, unless caused by intent or gross negligence or based on mandatory liability for injury of life, body or health The above provisions does not imply a change in the burden of proof to your detriment.

Copyright© 2008 Siemens A&D. It is not permissible to transfer or copy these application examples or excerpts of them without first having prior authorization from Siemens A&D in writing. For questions about this document please use the following e-mail address:

mailto:[email protected]

mailto:[email protected]�

Table of Contents


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Table of Contents

Table of Contents ......................................................................................................... 3

1 Introduction..................................................................................................... 4 1.1 In general.......................................................................................................... 4 1.2 Test environment .............................................................................................. 4 1.3 Equipment for the Windows active directory domain........................................ 5 1.4 Installed software.............................................................................................. 6

Operating system ......................................................................................... 6 SIMATIC software ........................................................................................ 6

2 ESIG - Electronic Signature ........................................................................... 7 2.1 SIMATIC Electronic Signature inside SIMATIC PCS 7..................................... 7 2.2 SIMATIC Electronic Signature inside SIMATIC IT............................................ 8 2.2.1 SIMATIC IT Compliance Service ...................................................................... 8 2.2.2 SIMATIC IT PPA and HDD ............................................................................... 8 2.2.3 SIMATIC Plant Definition Manager (PDefM)..................................................... 9 2.2.4 Example and usage of ESIG in PDefM........................................................... 13 2.2.5 SIMATIC Material Manager (MM)................................................................... 18 2.3 SIMATIC Compliance Services and viewer .................................................... 27 2.3.1 Compliance Service configuration .................................................................. 27 2.3.2 Filtering inside the CS viewer ......................................................................... 27 2.3.3 Using Profiles inside the CS viewer ................................................................ 28 2.3.4 SIMATIC PDefM inside the CS viewer ........................................................... 28 2.3.5 SIMATIC Material Manager inside the CS viewer .......................................... 29 2.4 Report Manager and Compliance Service...................................................... 30 2.4.1 Using the predefined report ............................................................................ 30 2.4.2 Creating a customized report from scratch..................................................... 37

3 References .................................................................................................... 42

4 Abbreviations................................................................................................ 43

Introduction


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1 Introduction

1.1 In general

General information, to the topic of how to set up a running domain, can be found in the knowledge management document “SIMATIC software in a domain”.

Here just an overview from the environment which is used to give the information to the topic “Electronic Signature in SIMATIC SIMATIC IT Production Suite (PRS)”

1.2 Test environment

The following scheme shows the Windows active directory domain computers:

Figure 1-1: Scheme of the Windows active directory domain computers

A private IP address band is used with fixed IP addresses.

http://support.automation.siemens.com/WW/view/en/26639558�


Introduction


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1.3 Equipment for the Windows active directory domain

• 2 Windows active directory domain controllers (DNS, WINS)

• 2 SIMATIC PCS 7 OS-Server (redundant)

• 2 SIMATIC BATCH-Server (redundant)

• 1 SIMATIC PCS 7 Engineering System (ES)

• 2 SIMATIC PCS 7 OS Multiclient + SIMATIC BATCH-Client

• 1 SIMATIC IT Production Suite Server (Production Modeler and Components)

• 1 SIMATIC IT Historian Server

• 1 SIMATIC IT Report Manager/ CAB engineering

• 1 SQL 2005 server for all SIMATIC IT databases (PPA DB, SITMesDB, Compliance Services DB)

• 1 SIMATIC AS CPU 417 with a CP 443-1

Introduction


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1.4 Installed software

Operating system The used operating systems for the domain computers can be found in the following table. Table 1-1

Station Installation

Windows 2003 MUI (Multilanguage User Interface) with SP2 Internet Explorer V6.0 SP2 (6.0.3790.3959)

Server

Image software Windows XP SP2 Client Image software Windows 2003 MUI (Multilanguage User Interface) with SP2 Domain Controller Internet Explorer V6.0 SP2 (6.0.3790.3959)

SIMATIC software SIMATIC software and its required software packages (e.g. message queuing, SQL Server 2005 with SPx, .....) are installed as needed. The installed software for SIMATIC PCS 7 and SIMATIC IT is the released “Integration Pack 2007” on top of the released SIMATIC Versions. Table 1-2

Product Version

V7.0 SP1

Microsoft SQL 2005 SP1 HF

SIMATIC PCS 7

PCS 7 / SIMATIC IT Integration Pack 2007 Part1 Updates SIMATIC PCS 7 V6.3 SP1 Microsoft SQL 2005 SP2 PCS 7 / SIMATIC IT Integration Pack 2007 Part2 Updates SIMATIC IT

SIMATIC IT

SIMATIC IT Report Manager HF1

ESIG - Electronic Signature


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2 ESIG - Electronic Signature

On the Wikipedia webpage (http://en.wikipedia.org/wiki/Electronic_signature) you can find currently several ways to define the word “electronic signature”. The most important one in the SIMATIC PCS 7 – SIMATIC IT field is the description for the FDA 21 CFR, article 11.

Food and Drug Administration 21 CFR Sec. 11.3 definitions

(5) Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

(7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

NOTE Please refer to the SIMATIC knowledge management document “SIMATIC Logon inside SIMATIC” as SIMATIC Logon is mandatory for the usage of the SIMATIC Electronic Signature software package.

2.1 SIMATIC Electronic Signature inside SIMATIC PCS 7

NOTE The complete topic about the configuration of Electronic Signatures in SIMATIC PCS 7 is described in the knowledge management document “Electronic Signature in SIMATIC PCS 7 and SIMATIC IT Historian”.

http://en.wikipedia.org/wiki/Electronic_signature�

http://en.wikipedia.org/wiki/Food_and_Drug_Administration�





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2.2 SIMATIC Electronic Signature inside SIMATIC IT

The next paragraphs give in an overview the usage of the Electronic Signature (Compliance Service) in SIMATIC IT.

2.2.1 SIMATIC IT Compliance Service

The following picture shows the usage of the Compliance Service (ESIG) in SIMATIC IT.

Figure 2-1 Compliance Service (ESIG) in SIMATIC IT

2.2.2 SIMATIC IT PPA and HDD

NOTE Please refer to the knowledge management “Electronic Signature in SIMATIC PCS 7 und SIMATIC IT Historian” where you can find detailed information about PPA and HDD.





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2.2.3 SIMATIC Plant Definition Manager (PDefM)

SIMATIC IT Product Definition Manager (PDefM) is a MES Component that provides a system for creating and editing production processes, specifying all the resources and steps or phases required to produce a specific final material or product. This component’s objective is to allow the user to configure a set of information that can be used to produce various products and minimize operator input during runtime. This is realized through the specification of Product Production Rules (PPRs), which are composed of Product Segments (PSs).

NOTE Inside the SIMATIC Plant Definition Manager (PDefM) the SIMATIC ESIG is supported and working if the FDA Mode of the PDefM server is enabled.

Figure 2-2 PDefM Server

Figure 2-3 FDA Mode of PDefM Server enabled



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To enable the FDA mode of the server you have to have a Compliance Service database enabled in your SIMATIC IT project. You can do this from the management console:

“Configuration > Complicance Server configuration“

The configuration of PDefM itself can be found inside the display of the PDefM under:

“Tools > Data Editor > Life Cycle Transitions“

Figure 2-75: Configuration of the PDefM ESIG

This opens the Life Cycle Transition Editor.

Choose in the Life Cycle the STD and in the Life Cycle Version 0001.00.

Figure 2-4 Configuration of the PDefM ESIG

NOTE The blue fields inside this table demonstrate the possible transitions.



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Figure 2-5 Possible Transitions of the PDefM

A doubleclick on one of the blue fields opens the Edit Transition dialog.


You have to check the checkmark “Electronic Signature Required“. Then you can browse with the button “…“ for a scenario which you have predefined in the user manager.



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For every possible status change inside PDefM we created one predefined scenario in the user manager.

Figure 2-8 Configuration of the PDefM ESIG inside the scenario view



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2.2.4 Example and usage of ESIG in PDefM

In the PDefM with: “PPR > New…” you can create a new PPR.

Figure 2-9 Creating a new PPR

The “Insert the name“ box pops up where you have to provide a name for the new Product Production Rule (PPR)




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The PPR opens. In the dialog box of the PPR you have to fill out the necessary infos in the areas:

• PPR

• Plant

• Life Cycle

• Final Material


Hit the button "OK" which closes the dialog.



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Back in the PDefM Display you can see the newly created PPR.

Figure 2-12 Changing the status of a PPR

With a right mouse click on the PPR you can choose “Change status…”




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This opens the dialog box “Change status of PPR <PPR-Name>”.


In the field “Change Status to:” you see the possible status changes.


Mark the status you want to perform and hit OK.



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This opens the ES Request box where you have to sign for this action.


The results of these signing actions can be seen in the Compliance Service Viewer.



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2.2.5 SIMATIC Material Manager (MM)

SIMATIC IT Material Manager (MM) is a MES Component that simplifies the management of materials as they move through manufacturing facilities.

The component allows the user to configure materials in terms of their classes and definitions. In runtime, each type of configured material can be tracked as it flows through the plant, and a collection of tracking information is provided in the complete genealogy of each material. This genealogy allows for immediate identification and provides precise information regarding issues of quality.

NOTE Inside the SIMATIC Material Manager (MM) the SIMATIC ESIG is directly supported if the Electonic Signature Management is enabled in the MOSC.

To enable SIMATIC Electronic Signature for the MM, go in the SIMATIC IT Management Console to the MOSC:

“Component > MES Options Servers Configurator (MOSC)“

Figure 2-17 Configuring the MM



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This opens the MOSC.




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Open the Advanced Options.


If the Material Manager server is stopped you can activate the Electronic Signature Management for the MM in the advanced options for the MM server with the option “Activate Electronic Signature Management”.



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After enabling the Electronic Signature option (ESIG) you can go to the Material Manager presentation client and open the “Electronic Signatures Management”.


In the Material Manager “Electronic Signatures Management” view you have the possibility to display only the active ES configurations with the checkmark “Show Only Active ES Configurations”.




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If you uncheck this checkbox you can see the complete predefined electronic signatures which are possible in MM.


With the button “Change Scenario“ (1) and the button “…“ (2) you can browse for a previous created scenario from the SIMATIC IT User Manager. With these functions you can assign for each possible status change of a material a scenario.




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We defined for every possible status change of a material a scenario inside the user manager.


The following default states of a material are available:

• n/a

• EDIT

• TEST

• READY

• APPROVED

• OBSOLETE



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The following default state changes inside the MM are possible.

Figure 2-25 Possible state changes inside the MM

Table 2-1

FROM To To To To To n/a EDIT TEST READY APPROVED OBSOLETE

EDIT - TEST - APPROVED OBSOLETE

TEST EDIT - READY - OBSOLETE

READY - - - APPROVED OBSOLETE

APPROVED EDIT - READY - OBSOLETE

OBSOLETE EDIT APPROVED



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After enabling for every possible default state change a scenario, it could look in the MM display as followed.

Figure 2-95: Configuring the MM

If you now perform the status change of a material, an ESIG box pops up where you have to sign for this status change.

Figure 2-26 Signing a configuration for the MM

NOTICE Remember that the user has to provide his user name in the form <domainname\username>.



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The statuschange of a material is done in the Material Manager display. Mark a material and then use the button "Change". This will open the sign box.

Figure 2-27 Changing the status of a material

NOTE The signing results can be seen in the SIMATIC Compliance Service Viewer. This application is explained later in this document.



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2.3 SIMATIC Compliance Services and viewer

See the document “Electronic Signature in SIMATIC PCS 7 and SIMATIC IT Historian” for the basic description of the Compliance Services and viewer. In this chapter the description for PDefM and MM inside the Compliance Service Viewer are made.

NOTE The Compliance Service Server has to be started every time you restart the system in order to enable the Compliance Service functions. Use the autostart function of the management console to do this.

2.3.1 Compliance Service configuration

Before you can use the Compliance Service in its full functionality you have to configure it. You can do this by opening the "Compliance Service Configuration" from the management console:

“Configuration > Compliance Service Configuration”

2.3.2 Filtering inside the CS viewer

A very good possibility to find entries inside the CS viewer is the filtering. You can open the “Set Filter” dialog with the button marked in red.

Figure 2-28 Compliance Service Viewer Set Filter

With the filtering for an ApplicationID and the field OP %LIKE%, you can very easily create CS views with the relevant data.

NOTE For more detailed information about filtering see the document “Electronic Signature in SIMATIC PCS 7 and SIMATIC IT Historian”.







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2.3.3 Using Profiles inside the CS viewer

After having applied a custom filter to the CS viewer you might want to reuse this filter at a later time. For this case you can save the view as a profile, with a name which is self explaining:

“File > Save Profile…”

After having done this for your custom filters you can reload your filters with

“File > Load Profile…”

2.3.4 SIMATIC PDefM inside the CS viewer

The PDefM Electronic Signatures actions are written to the CS viewer. You can use the filter inside the CS viewer to show only actions releated to PDefM.

Figure 2-29 Filter settings for PDefM in CS viewer

NOTE The ApplicationID you can search for in the CS viewer for entries from the PDefM is “PDefM”.

Figure 2-30 CS viewer with filtered ESIGs from PDefM



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2.3.5 SIMATIC Material Manager inside the CS viewer

The MM Electronic Signatures actions are written to the CS viewer. You can use the filter inside the CS viewer to show only actions related to MM.

Figure 2-31 Filter settings for PDefM in CS viewer

NOTE The ApplicationID you can search for, in the CS viewer for entries coming from the Material Manager, is “MMSrv”.

Figure 2-32 CS viewer with ESIGs from MM



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2.4 Report Manager and Compliance Service

If you want to use the Report Manager for creating reports based on the Compliance Service, you have to configure the Report Manager, to do this. The needed steps are explained in the document “Electronic Signature in SIMATIC PCS 7 and SIMATIC IT Historian”.

NOTE To use this function in Report Manager you have to have at least the HF1 from RM installed.

2.4.1 Using the predefined report

To use a predefined report of the Report Manager (RM) you have to start the tool Reporter of the RM.

“All Programs > SIMATIC > SIMATIC IT > Components > Report Manager (RM) > Reporter”

Figure 2-33 Using a predefined report of the RM

Provide the correct password.





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The window “New Report Wizard” opens.


Use the Button “Cancel”. Then with “File > Open” you can open the “Open” window from where you can choose a predefined report of the format *.rep.




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We choose the “CS OverviewReport.rep” and this opens the predefined report for the Compliance Service.




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With the button “Refresh Data” you can choose the data to be displayed.


Select the time range for the CS to be displayed.




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Use the “Values…” button to choose from a list of possible values for the Action and the User.


For the action the "List of Values of AT Action might" look like this.


Choose the AT Action you desire – e.g. ChangeDefStatus: EDIT-OBSOLETE



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Use the "%" as a possible placeholder in the Select options for the user.


After applying the selections with the button "OK" the predefined report opens with the values selected.




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A report can be saved in several formats for further usage.


Possible formats for saving a report are:

• *.rep

• *.rtf

• *.txt

• *.pdf

• *.xls

• *.htm

• *.ret

• *.rea



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2.4.2 Creating a customized report from scratch

To create a customized report from scratch you have to start the tool Reporter of the RM. After having provided a correct login the following page is shown. In this welcome screen use the button “Begin >” to create a customized report from scratch.

Figure 2-44 Creating a customized report from scratch



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Choose "Universe" and push the button “Next >”.




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Choose the compliance Universe (Univ. CS25062008_CS) and push the button “Finish”.


NOTE In our case the CS Universe is called “Univ. CS25062008_CS” – where CS25062008 is the name of the Compliance Service Database. This makes it very likely that the Univers you have to choose has a differnet name.



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This is the query panel which opens after your settings.


From here you can move from the "Classes and Objects" side (on the left) via drag and drop the desired data to the "Result Objects" window frame (on the right).



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Run the query and a customized CS report will be generated.


Also this report can now be saved with a customized name and we have created our customized report.


References


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3 References

from the web:

http://www.fda.gov/ora/compliance_ref/part11/Default.htm

http://en.wikipedia.org/wiki/Electronic_signature

from SIEMENS sources:

SIMATIC Logon and ESIG help “slogon_b.pdf”

SIMATIC IT online help

SIMATIC IT Compliance Service help “cseng.chm”

SIMATIC IT Report Manager help files

Security Handbook

Helpfiles

C:\Program Files\SIEMENS\Documentation\English

Service and Support Automation and Drives

http://support.automation.siemens.com/WW/view/en/26639558

http://www.fda.gov/ora/compliance_ref/part11/Default.htm�

http://en.wikipedia.org/wiki/Electronic_signature�


Abbreviations


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4 Abbreviations

In this manual are used several abbreviations. Please find here the corresponding complete name. Table 4-1

Abbreviation Complete name

AD Active Directory AT Audit Trail BPM Business Process Modeler BCC Batch Control Center CAB Client Application Builder CH_DI CHannel Digital Input CH_DO CHannel Digital Output CIL Cross Industry Library CP Communication Processor CPU Central Processor Unit CS Compliance Service DB Data Base DCOM Distributed Component Object Model DHCP Dynamic Host Configuration Protocol DCS Distribution Control System DIS Data Integration Service DNS Domain Name Service ES Engineering System ESIG Electronic SIGnature FAQ Frequent Asked Question FDA Food and Drug Administration GMP Good Manufacturing Practice HDD Historical Data Display HF Hot Fix HMI Human Machine Interface IP Internet Protocol ISA Industry Standard Architecture MES Manufacturing Execution System MM Material Manager MOSC MES Options Servers Configurator MR Master Recipe MUI Multilanguage User Interface OPC Ole for Process Communication

Abbreviations


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Abbreviation Complete name

OS Operator-Station OSM Optical Switch Module OU Organizational Unit PLC Programmable Logical unit PPA Plant Performance Analyzer PDA Plant Data Archive PDefM Production Definition Manager PPR Product Production Rule PRS Production Suite RAID Redundant Array of Independent Disks RM Report Manager RTDS Real Time Data Server SFC Sequence Function Chart SIT SIMATIC IT SQL Structured Query Language SP Service Pack UPS Uninterruptible Power Supplies WINS Windows Internet Naming Service

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