EU GMP Annex 11 — Gap Analysis
EU GMP Annex 11 — Computerised Systems in Pharmaceutical ManufacturingAbout EU GMP Annex 11
EU GMP Annex 11 covers computerised systems used in pharmaceutical and medical-product manufacturing within the European Union. It is part of EudraLex Volume 4 and was last revised in June 2011. Annex 11 applies a risk-based approach, requires comprehensive validation aligned with GAMP 5, mandates data integrity controls, supports 21 CFR Part 11 equivalence for electronic signatures, and addresses suppliers, business continuity and incident management. It is widely recognised globally through PIC/S adoption.
Issuing Body
European Medicines Agency (EMA) — EudraLex Volume 4
Edition
2011
Coverage
Computerised systems used as part of GMP regulated activities — risk-based validation, data integrity, electronic signatures, suppliers, business continuity.
Typical Users
EU pharmaceutical manufacturers, MAHs, contract manufacturers — and globally as a recognised harmonised standard (PIC/S adoption).
How to use this tool
1. Work through each clause. For each requirement, choose Compliant, Partial, Non-compliant, or leave as Not assessed.
2. Add notes against any requirement to record evidence, gaps, or corrective actions.
3. Click Save progress — data is stored locally in your browser, never uploaded.
4. Export the report as TXT, CSV, JSON or print to PDF for your audit file.
Note: This tool is a guided self-assessment. It does not replace a third-party audit and the authoritative version of the standard must be obtained from the issuing body.
ISO Xpert — Get in touch
UK-based consultancy specialising in management-system gap analysis, training and certification preparation across ISO, API, Halal, GFSI, ESG, cybersecurity and industry-specific standards.
Phone / WhatsApp
Office
71-75 Shelton Street, Covent Garden, London WC2H 9JQ, UK