New GAMP® Good Practice Guide "Electronic Data Archiving"

GMP News
22 October 2007
 

New GAMP® Good Practice Guide "Electronic Data Archiving"

 
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

 

In the European Compliance Academy (ECA) Courses

experts from the pharmaceutical industry and from the GAMP Committee will show you efficient ways to validate your computerised systems and how to maintain this validated state during routine operation.

 
Prepared by:
Dr. Andreas Mangel
On behalf of the European Compliance Academy (ECA)
 

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