GxP Computer System Validation
GxP computer system validation per GAMP 5, 21 CFR Part 11, EU GMP Annex 11. URS, FDS, IQ, OQ, PQ, validation master plans, CSA implementation.
Overview
GxP computer system validation per GAMP 5, 21 CFR Part 11, EU GMP Annex 11. URS, FDS, IQ, OQ, PQ, validation master plans, CSA implementation.
How to use this page
Use this GxP Computer System Validation page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For GxP Computer System Validation, prepare the records, owners, risks and decision criteria linked to overview. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.