EMC Documentum for LifeSciences LifeSciences Version4.2 AdministrationGuide EMCCorporation CorporateHeadquarters Hopkinton,MA01748-9103 1-508-435-1000

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  • EMC Documentum forLife Sciences

    Version 4.2

    Administration Guide

    EMC CorporationCorporate Headquarters

    Hopkinton, MA 01748-91031-508-435-1000www.EMC.com

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  • Table of Contents

    Preface ................................................................................................................................ 13

    Chapter 1 Life Sciences Solution Fundamentals ......................................................... 15Overview ......................................................................................................... 15Document Domains .......................................................................................... 16Roles ............................................................................................................... 18Administrators ............................................................................................. 20Document Approvers ................................................................................... 20Document Auditors ...................................................................................... 21Document Authors ....................................................................................... 22Document Contributors (LSTMF) .................................................................. 23Document Coordinators................................................................................ 23Document Quality Organization Approvers (LSQM) ...................................... 24Document Readers ....................................................................................... 25Document Reviewers .................................................................................... 26Managers (Product, Project, Trial, Study, Regulatory) ...................................... 26Controlled Printers (LSQM) .......................................................................... 27Global External Participants (LSTMF) ............................................................ 28Inspectors (LSTMF) ...................................................................................... 28Investigators (LSTMF) .................................................................................. 28Quality Check (LSTMF) ................................................................................ 29Solution-Specific User Roles .......................................................................... 29User Roles in Documentum eTMF ............................................................. 29Cross-functional User Groups ............................................................... 30Reporting Groups................................................................................. 31External Trial Participant Roles .............................................................. 31External Trial Participant Groups........................................................... 32

    User Roles in Documentum Q&M.............................................................. 34Cross-functional User Groups ............................................................... 36Reporting Groups................................................................................. 36

    User Roles in Documentum R&D............................................................... 36Cross-functional User Groups ............................................................... 40Reporting Groups................................................................................. 40

    User Roles in Documentum SSV ................................................................ 40Correspondence User Groups................................................................ 41Cross-functional User Groups ............................................................... 42Reporting Groups................................................................................. 42

    Control Categories............................................................................................ 43

    Chapter 2 Customizing D2-Based Solutions ................................................................ 45Extending D2-Based Life Sciences Solutions ....................................................... 45Creating a Custom Application ..................................................................... 45Modifying or Extending a Base Configuration ................................................ 46Extending the Base Solution Contexts ............................................................ 46

    Upgrading the Customized Solution .................................................................. 47Reconciling Extended Base Configurations with Solution Upgrades................. 48

    3

  • Table of Contents

    Merging D2 Configuration XML Files ............................................................ 48Best Practices for Team Development with D2 .................................................... 49Extending Roles ............................................................................................... 50Creating Custom Roles ................................................................................. 50Configuring the Property Pages ..................................................................... 50Configuring Workflows ................................................................................ 50Configuring Roles (LSQM) ............................................................................ 51

    Chapter 3 Life Sciences Data Model ............................................................................ 53Data Model Overview....................................................................................... 53Add or Modify Attributes in Existing Solution Types .......................................... 55Create New Types that Extend from Existing Solution Types ............................... 56

    Chapter 4 Reference Models ........................................................................................ 57Standard Solution Implementation of the DIA EDM Reference Model.................. 57Standard Solution Implementation of the DIA TMF Reference Model .................. 64Standard Solution Implementation of Quality and ManufacturingDocument Models ............................................................................................ 66Implementation of the DIA EDM Reference Model for the RegulatoryDomain (LSRD) ................................................................................................ 68Extending the Standard Reference Model Implementation (LSTMF) .................... 70Extending Dictionaries.................................................................................. 70File Plans and File Plan Templates ................................................................. 71

    Implementing a Custom Reference Model (LSTMF) ............................................ 71

    Chapter 5 Document Creation Profile .......................................................................... 73Management Creation Profiles .......................................................................... 73Document Creation Profiles .............................................................................. 74Control Category Definition .............................................................................. 76Default Values Template ................................................................................... 76Customizing Creation Profiles ........................................................................... 78Creating a New Creation Profile .................................................................... 78Changing Creation Profile Properties ............................................................. 79Changing Creation Properties for an Artifact within an ExistingCreation Profile ............................................................................................ 79Adding Artifacts to an Existing Creation Profile ............................................. 79Removing Artifacts from an Existing Creation Profile ..................................... 80Removing or Disabling an Existing Creation Profile ........................................ 80

    File Naming and Versioning .............................................................................. 81Versioning of Virtual Documents ................................................................... 81Binding Rules for Change Requests ............................................................... 82

    O2 Configuration for PDF and Native Annotations ............................................. 83C2 View Con

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