Complass
Computerised systems in GxP environments: Annex 11, Part 11 and the risk-based approach
The inspector wants to see the audit trail of a test result, the US customer asks about Part 11, and the new Annex 11 is not final yet: how to validate and operate computerised systems with a risk-based approach.
EU GMP Annex 11 and 21 CFR Part 11 set out how computerised systems in medicinal product manufacturing and for the US market are validated and operated, and when electronic records and signatures are considered trustworthy. They affect manufacturers, testing laboratories and contract manufacturers, and indirectly their software, SaaS and IT suppliers.
The whitepaper quotes both texts with their references, sets out the status of the Annex 11 revision and the draft Annex 22 with dates, explains the FDA's Computer Software Assurance and the risk-based approach in its own words, shows the overlap with NIS2 and ISO/IEC 27001, and closes with a ten-step roadmap and an entry checklist.
Short "Implementation in Complass" boxes name only features available today; Complass is not your GxP system and makes no conformity statement.
17 pages · Version 1.1 · as of · Author Marc Linden, Complass GmbH
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