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Wednesday, October 6, 2010

The New GAMP Good Practice Guide: How to Operate Computerised Systems in a GMP-Compliant Way

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.
01. Introduction 02. Overview of the Operation Phase03. What Organizations Should Do04. Process Relationships05. Handover06. Establishing and Managing Support Services07. Performance Monitoring08. Incident Management09. Corrective and Preventive Action10. Operational Change and Configuration Management11. Repair Activity12. Periodic Review13. Backup and Restore14. Business Continuity Management15. Security Management16. System Administration17. Data Migration18. System Retirement, Decommissioning, and Disposal19. Appendix 1 - RACI Roles and Operational Processes 20. Appendix 2 - Mapping of Operational Processes to ITIL® and COBIT®21. Appendix 3 - List of Control Records22. Appendix 4 - References23. 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.
This is pasted from GMP Compliance website

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