Computerised Systems
Establishes requirements for computerised systems used in GxP-regulated activities. Covers validation, data integrity, access control, audit trails, and disaster recovery. The EU counterpart to FDA 21 CFR Part 11.
All GxP computerised systems in EU-regulated facilities including LIMS, DCS, SCADA, MES, ERP modules used for GxP purposes, and QMS software.
- 01Risk-based approach to validation — system inventory with GxP impact assessment
- 02Supplier assessment and ongoing monitoring for commercial off-the-shelf (COTS) systems
- 03Validation documentation: URS, FS, CS, IQ, OQ, PQ with traceability matrix
- 04Data integrity controls: access management, audit trails, backup/restore procedures
- 05Change management — all changes go through formal change control with impact assessment
- 06Periodic review of validated systems — evidence of continuing validated state
Current version June 2011. Under revision — EU GMP Annex 11 rev draft expected 2025. Monitor EMA website. ISPE GAMP 5 (2022) is the primary implementation reference.
EU GMP Annex 11: frequently asked questions
Quick answers to common questions about EU GMP Annex 11.
What is EU GMP Annex 11?
EU GMP Annex 11 — Computerised Systems — is a regulation issued by the European Medicines Agency (European Union). Establishes requirements for computerised systems used in GxP-regulated activities. Covers validation, data integrity, access control, audit trails, and disaster recovery. The EU counterpart to FDA 21 CFR Part 11.
Who does EU GMP Annex 11 apply to?
All GxP computerised systems in EU-regulated facilities including LIMS, DCS, SCADA, MES, ERP modules used for GxP purposes, and QMS software.
What are the key requirements of EU GMP Annex 11?
EMA EU GMP Annex 11 requires, among other things: Risk-based approach to validation — system inventory with GxP impact assessment; Supplier assessment and ongoing monitoring for commercial off-the-shelf (COTS) systems; Validation documentation: URS, FS, CS, IQ, OQ, PQ with traceability matrix; Data integrity controls: access management, audit trails, backup/restore procedures.
When was EU GMP Annex 11 last updated?
The current version of EU GMP Annex 11 dates from June 2011. Current version June 2011. Under revision — EU GMP Annex 11 rev draft expected 2025. Monitor EMA website. ISPE GAMP 5 (2022) is the primary implementation reference.
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Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When EU GMP Annex 11 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.