2008 saw the publication of version 5 of the GAMP® Guide and thus the creation of a standard for the validation of computerised systems, which is accepted all over the world, and required in some parts, too. Even though GAMP®5 covers the complete life cycle of computerised systems, the main focus is on the necessary validation activities. Some basic activities of the (GMP-compliant) operation are already described in GAMP®5 in the "O" appendices (O for operation).
These operation-related appendices served as the basis for the creation of a GAMP GPG (Good Practice Guide) "A Risk-Based Approach to Operation of GxP-Computerized Systems - A Companion Volume to GAMP®5" published at the beginning of 2010. GPGs are based on the GAMP®5 and focus on specific areas within the life cycle (e. g. testing) or on particular IT systems (e. g. MES systems).
The structure of this GPG follows, as far as this is possible, the structure of the operation-related GAMP®5 appendices.
02. Overview of the Operation Phase
03. What Organizations Should Do
04. Process Relationships
06. Establishing and Managing Support Services
07. Performance Monitoring
08. Incident Management
09. Corrective and Preventive Action
10. Operational Change and Configuration Management
11. Repair Activity
12. Periodic Review
13. Backup and Restore
14. Business Continuity Management
15. Security Management
16. System Administration
17. Data Migration
18. System Retirement, Decommissioning, and Disposal
19. Appendix 1 - RACI Roles and Operational Processes
20. Appendix 2 - Mapping of Operational Processes to ITIL® and COBIT®
21. Appendix 3 - List of Control Records
22. Appendix 4 - References
23. Appendix 5 - Glossary
On balance one can say that the GMP-regulated environment places more and more emphasis on the operational phase of computerised systems. As a complement to the GAMP®5 Guide, the GAMP GPG "A Risk-Based Approach to Operation of GxP-Computerized Systems - A Companion Volume to GAMP®5" gives excellent guidance for daily practice.
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Dr Andreas Mangel
On behalf of the European Compliance Academy (ECA)
GAMP® is a trademark of ISPE - http://www.ispe.org/gamp5