EMC Documentum Researchand .EMC®Documentum®Researchand Development Version4.0 UserGuide EMCCorporation

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  • EMC Documentum Research andDevelopment

    Version 4.0

    User Guide

    EMC CorporationCorporate Headquarters

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

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  • Table of Contents

    Preface ................................................................................................................................. 7

    Chapter 1 Overview ...................................................................................................... 9Research and Development ............................................................................... 10Registration Forms ........................................................................................... 11Regulatory Labeling Documents........................................................................ 11Regulatory Safety Documents............................................................................ 13Clinical Crossover Documents........................................................................... 13Virtual Documents ........................................................................................... 14

    Chapter 2 Roles ........................................................................................................... 15Administrators ................................................................................................. 15Managers ......................................................................................................... 16Product Manager.......................................................................................... 16Regulatory Manager ..................................................................................... 16Clinical Trial Manager................................................................................... 17Non-clinical Study Manager .......................................................................... 17Quality Project Manager ............................................................................... 17Labeling Manager......................................................................................... 18Safety Manager ............................................................................................ 18

    Authors ........................................................................................................... 19All Authors .................................................................................................. 19Regulatory Authors ...................................................................................... 19Regulatory Publisher .................................................................................... 20

    Reviewers ........................................................................................................ 20Approvers........................................................................................................ 21Coordinators .................................................................................................... 21Readers............................................................................................................ 22Auditors .......................................................................................................... 22

    Chapter 3 Create Registration Forms .......................................................................... 23Creating a Product Registration Form ................................................................ 23Creating a Quality Project Registration Form...................................................... 25Creating a Regulatory Application Registration Form ......................................... 26Creating a Clinical Trial Registration Form ......................................................... 27Creating a Clinical Trial Registration Form for Crossover Documents .................. 28Creating a Non-clinical Study Registration Form ................................................ 29Registration Form Lifecycle Models ................................................................... 30Product Registration Form Lifecycle .............................................................. 30Clinical Trial Registration Form Lifecycle ....................................................... 31Non-Clinical Study Registration Form Lifecycle ............................................. 31

    3

  • Table of Contents

    Quality Project Registration Form Lifecycle .................................................... 33Regulatory Application Registration Form Lifecycle ....................................... 33

    Restrict Access to Registration Forms ................................................................. 34Assign Users to Roles........................................................................................ 35Registration Form Changes that apply to Existing Documents ............................. 35Changing a Product Code for a Product ......................................................... 36Changing Product-related Information for a Product ...................................... 37Changing Project Information ....................................................................... 38Changing Clinical Trial Information............................................................... 38Updating the Regulatory Application Number ............................................... 38

    Chapter 4 Create Documents ....................................................................................... 39Controlled Documents ...................................................................................... 39Creating a Controlled Document ................................................................... 40Creating a Regulatory Administrative, Labeling, or Safety Document .............. 43Creating a Relation between Labeling Documents .......................................... 44Updating the Labeling Status ........................................................................ 44Creating a Non-clinical, Clinical, or Quality Document ................................... 45Associating a Document with a Regulatory Application .................................. 45Creating a Clinical Crossover Document ........................................................ 46Creating a Clinical Study Report Assembly Virtual Document......................... 48Creating a Copy of a Controlled Document (Technology Transfer) ................... 48Assigning Users to Roles for a Controlled Document ...................................... 50Creating a Non-controlled Document ............................................................ 51File Naming and Versioning .......................................................................... 51Importing a File from your Computer ............................................................ 51

    Document Updates ........................................................................................... 52Editing a Document ...................................................................................... 52Checking in a Document ............................................................................... 52

    Configuring Content Templates ......................................................................... 53Creating a Content Template ......................................................................... 53Modifying a Content Template ...................................................................... 55

    Chapter 5 Working with Documents ............................................................................ 57Locating Documents ......................................................................................... 57Finding Documents using a Public Search .......................................................... 57Finding Documents using Facets ....................................................................... 58Viewing Documents and their Properties ........................................................... 59Viewing the Document History ......................................................................... 59Deleting and Restoring a Document................................................................... 59Exporting the Doc List to Microsoft Excel ........................................................... 60Finding Documents .......................................................................................... 61

    Chapter 6 Review and Approve Documents ................................................................ 63Workflow Process ............................................................................................. 63Document Review