Is Annex 11 applicable to all GxP systems?
Annex 11 applies to computerized systems used in the EU GMP environment.
EU GMP Annex 11 Compliance
EU GMP Annex 11 compliance services for pharmaceutical GxP systems. The engagement covers the Annex 11 gap analysis, the remediation roadmap, and the implementation support.
Annex 11 requirements
EU GMP Annex 11 covers computerized systems in the EU regulatory environment. Key requirements include system validation, audit trail, electronic signatures, access control, data integrity, periodic review, and supplier management.
Annex 11 gap analysis
An Annex 11 gap analysis reviews the GxP systems against the Annex 11 requirements. The analysis identifies gaps, classifies them by risk, and prioritizes them for remediation.
Periodic review and supplier management
Two Annex 11 requirements often under-implemented are the periodic review of the GxP system and the supplier management.
How to use this page
Use this EU GMP Annex 11 Compliance 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 EU GMP Annex 11 Compliance, prepare the records, owners, risks and decision criteria linked to annex 11 requirements, annex 11 gap analysis, periodic review and supplier management. 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.
Frequently asked questions
How does Annex 11 differ from Part 11?
Annex 11 (EU) and Part 11 (FDA) cover similar requirements with differences in scope, audit trail, and electronic signatures.