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[EN] "Electronic Records Management: Why re-invent the wheel?" | Presentation | Christoph Jeggle | PROJECT CONSULT | 01.12.2009

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"Electronic Records Management: Why re-invent the wheel?" | Presentation | Christoph Jeggle | PROJECT CONSULT | 01.12.2009


Topics
- Why Reinvent The Wheel?
- Key Processes of RM
- Types of Standards
- Metadata
- Data Formats
- Generic Standards
- ISO 15489
- MoReq2
- Selected Functional Requirements
- Summary
- MoReq2 compared to 21 CFR Part 11



The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
 
These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.

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[EN] "Electronic Records Management: Why re-invent the wheel?" | Presentation | Christoph Jeggle | PROJECT CONSULT | 01.12.2009

  1. 1. Electronic Records Management: Why re-invent the wheel ? Christoph Jeggle, Senior Consultant PROJECT CONSULT
  2. 2. www.diahome.org The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Disclaimer
  3. 3. www.diahome.org Why Reinvent The Wheel? • (Electronic) Records Management is regulated by many standards  Are these standards useful for implementation and operation of (E)RM in the pharmaceutical industry?
  4. 4. www.diahome.org Key Processes of RM RECORDS
  5. 5. www.diahome.org …Covered by Standards RECORDS Moreq2 ISO 15489 XML Metadata: DC, ISAAR, ISOs 23081, 2788, 5964 ISO 18492, OAIS X.509, XKMS ISO 12142 ISO 15801, 12654 ISO 12033 PDF/A RFC 2821, 2822, TIFF, JPEG ISO 216 ISO 12037 GUID PDF/A ISO 15801, 12654
  6. 6. www.diahome.org Types of Standards • Terminology • Procedures and Methods • Metadata • Data Formats • Interfaces
  7. 7. www.diahome.org Example 1: Metadata RECORDS Moreq2 ISO 15489 XML Metadata: DC, ISAAR, ISO 23081 ISO 2788 ISO 5964 ISO 12142 ISO 15801, 12654 ISO 12033 PDF/A RFC 2821, 2822, TIFF, JPEG ISO 216 ISO 12037 GUID ISO 15801, 12654
  8. 8. www.diahome.org Metadata Standards DC Dublin Core ISAAR International Standard Archival Authority Record for Corporate Bodies, Persons, and Families ISO 23081 Information and documentation -- Records management processes -- Metadata for records ISO 2788 Documentation -- Guidelines for the establishment and development of monolingual thesauri ISO 5964 Documentation -- Guidelines for the establishment and development of multilingual thesauri
  9. 9. www.diahome.org Example 2: Data Formats RECORDS Moreq2 ISO 15489 XML Metadata: DC, ISAAR, ISOs 23081, 2788, 5964 ISO 18492, OAIS X.509, XKMS ISO 12142 ISO 15801, 12654 ISO 12033 PDF/A RFC 2821, 2822, TIFF,JPEG ISO 216 ISO 12037 GUID PDF/A ISO 15801, 12654
  10. 10. www.diahome.org Generic Standards RECORDS MoReq2 ISO 15489 XML Metadata: DC, ISAAR, ISOs 23081, 2788, 5964 ISO 18492, OAIS X.509, XKMS ISO 12142 ISO 15801, 12654 ISO 12033 PDF/A RFC 2821, 2822, TIFF, JPEG ISO 216 ISO 12037 GUID PDF/A ISO 15801, 12654
  11. 11. www.diahome.org ISO 15489 • Definition of meaning, function and elements of Records Management Systems  Limited value for implementations of Records Management Systems
  12. 12. www.diahome.org MoReq2 • Model Requirements for the management of electronic records – Prepared for the European Commission – Reviewed also by pharmaceutical organisations • National Agency for Medicines, Finland • Royal Pharmaceutical Society of GB
  13. 13. www.diahome.org MoReq2 • First version published in 2001 • Second version published in 2008 – adaption to the impact of technological changes – introducing independent compliance testing
  14. 14. www.diahome.org MoReq2 Content Requirements Compliance Testing Metadata
  15. 15. www.diahome.org MoReq2 Requirements • Terminology and key requirements • Functional requirements • Non-functional requirements • Metadata Requirements
  16. 16. www.diahome.org MoReq2 – Functional Requirements • Core Requirements – Classification scheme and file organisation – Controls and security – Retention and disposition – Capturing and declaring records – Referencing – Searching, retrieval and presentation – Administrative functions
  17. 17. www.diahome.org MoReq2 – Functional Requirements • Optional Requirements – Management of Physical (Non-electronic) Files and Records – Disposition of Physical Records – Document Management / Collaborative Working – Workflow – Casework
  18. 18. www.diahome.org MoReq2 – Functional Requirements • Optional Requirements (continued) – Integration with Content Management Systems – Electronic Signatures – Encryption – Digital Rights Management – Distributed Systems – Offline and Remote Working – Security Categories
  19. 19. www.diahome.org MoReq2 - Terminology • Generic terminology, not adapted to the pharmaceutical industry • User-centred, not technical terminology
  20. 20. www.diahome.org MoReq2 – Key Concept
  21. 21. www.diahome.org Selected Functional Requirements • Concept for complex records (several components linked to each other) • Physical records including hybrid records • Vital records
  22. 22. www.diahome.org Selected Functional Requirements • Audit Trail • Reason for changes
  23. 23. www.diahome.org Selected Functional Requirements • Electronic Signature – Advanced electronic signature according European „Directive on an Community Framework for Electronic Signatures“ 1999/93/EC
  24. 24. www.diahome.org Selected Functional Requirements • Disposal holds • Logical and/or physical deletion • Metadata stub after destruction
  25. 25. www.diahome.org How To Use MoReq2? Functional requirements as repository for User Requirement Specification – Very detailed, describing all options – Using MoReq2 terminology  Copy and Paste from MoReq2 to URS not recommended
  26. 26. www.diahome.org Functional Requirement Example
  27. 27. www.diahome.org MoReq2 Metadata • Comprehensive metadata model • Includes all elements of the MoReq2 specification • Detailed description of all metadata elements • Including XML schema
  28. 28. www.diahome.org How To Use MoReq2? Good starting point for enterprise-wide metadata model
  29. 29. www.diahome.org MoReq2 Metadata Example
  30. 30. www.diahome.org MoReq2 Compliance Testing • Test Framework for MoReq2 • Structured as a set of testing modules corresponding with the requirement modules • Including test data
  31. 31. www.diahome.org How To Use MoReq2? Testing framework usable as test script
  32. 32. www.diahome.org Compliance Testing Example
  33. 33. www.diahome.org Summary Requirements Compliance Testing Metadata
  34. 34. www.diahome.org Summary • MoReq2 – Detailed specification of • requirements, • metadata and • compliance testing – Closely related to each other
  35. 35. www.diahome.org MoReq2 compared to 21 CFR Part 11 21 CFR Part 11 MoReq2 Open vs. closed system - Electronic record Component, document, record Digital signature Electronic signature Electronic signature - Audit trail Audit trail Validation - Training -
  36. 36. www.diahome.org How To Use MoReq2? • Requirements, metadata and test frameword together usable for – Records Management system • selection, • implementation • validation
  37. 37. www.diahome.org MoReq2 – Current Situation • Certification – Until now: Only one RM product certified • Fabasoft Folio 2009 (Austrian manufacturer) • Chapter 0 (national requirements) – Until now: Only available in the French translation
  38. 38. www.diahome.org MoReq2 Links • http://www.moreq2.eu/ • http://ec.europa.eu/transparency/archiv al_policy/moreq/index_en.htm
  39. 39. www.diahome.org Thank you for your attention Christoph Jeggle christoph.jeggle@project-consult.com http://www.project-consult.com

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