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In the pharmaceutical environment, electronic data are subject to versatile and
frequently also long storage periods and have therefore to be archived. Due to
the fast technological development of IT devices and due to the prevalent lack
of knowledge relative to the long-term stability of the used media, the
archiving of electronic data has to be planned thoroughly.
For that purpose the new GAMP Good Practice Guide (GPG) "Electronic Data
Archiving" has been available for a few weeks now. The contents have partly been
addressed in the present GAMP 4 Guide already or will be introduced in the new
GAMP 5. Still, this guide can be seen as a good summary.
This guide contains a rational and scaleable approach for electronic data
archiving, provides support for developing and implementing an archiving
strategy as well as for selecting archiving tools. It also facilitates an
efficient long-term maintenance of electronic records.
Similar to the setup of the GAMP Guide the GPG is comprised of four main
chapters and ten appendices.
Topics of the main chapters:
- Introduction - Overview, Purpose, Benefits, Key Concepts, …
- Overview of Archiving - Archiving Definitions (Driving Forces to Archive, Paper
and Electronic Archiving, Options for Archiving, Electronic Data Archive System
Lifecycle, Main Archiving Processes)
- Creating and Implementing an Archiving Strategy - Definition and Implementation
of an Archiving Strategy (Scope, Requirements, Investigate Available Solutions,
Document Findings, Implement Strategy)
- Considerations When Archiving - Directions for Archiving (Summary of Archiving
Issues, Migration and Deletion of Records/Data, Retirement of the Archive
System, Special Considerations)
Topics of the Appendices:
- Appendix A: Example Regulatory Requirements
- Appendix B: The OAIS Reference Model (Open Archival Information System)
(ISO-Norm 14721)
- Appendix C: Metadata
- Appendix D: Databases
- Appendix E: Laboratory Systems
- Appendix F: Archiving Approaches
- Appendix G: Archiving Strategy Template
- Appendix H: Good Practices
- Appendix I: Glossary
- Appendix J: References
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