Risk ManagementEuropean Union (EMA/EC)
EU GMP Annex 11 — Computerised Systems
EU GMP Annex 11 (revised 2011) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used in pharmaceutical manufacturing and quality control. Published by the European Commission as part of EudraLex Volume 4.
Domains
Operational Phase — Release and Continuity
Operational Phase — Security and Access
Operational Phase — Change and Configuration
Operational Phase — Data Management
Project Phase
Compare EU GMP Annex 11 — Computerised Systems
EU GMP Annex 11 — Computerised Systems vs ISO 27001:2022View comparison →EU GMP Annex 11 — Computerised Systems vs SOC 2View comparison →EU GMP Annex 11 — Computerised Systems vs NIST CSF 2.0View comparison →EU GMP Annex 11 — Computerised Systems vs GDPRView comparison →EU GMP Annex 11 — Computerised Systems vs HIPAAView comparison →EU GMP Annex 11 — Computerised Systems vs PCI DSS 4.0View comparison →
EU GMP Annex 11 — Computerised Systems by Industry
EU GMP Annex 11 — Computerised Systems for Healthcare→EU GMP Annex 11 — Computerised Systems for Financial Services→EU GMP Annex 11 — Computerised Systems for Technology→EU GMP Annex 11 — Computerised Systems for Government→EU GMP Annex 11 — Computerised Systems for Manufacturing→EU GMP Annex 11 — Computerised Systems for Energy→EU GMP Annex 11 — Computerised Systems for Retail→EU GMP Annex 11 — Computerised Systems for Education→
EU GMP Annex 11 — Computerised Systems by Role
EU GMP Annex 11 — Computerised Systems for CISOs→EU GMP Annex 11 — Computerised Systems for Compliance Officers→EU GMP Annex 11 — Computerised Systems for Risk Managers→EU GMP Annex 11 — Computerised Systems for IT Directors→EU GMP Annex 11 — Computerised Systems for DPOs→EU GMP Annex 11 — Computerised Systems for Auditors→
Frequently Asked Questions
What is EU GMP Annex 11?
EU GMP Annex 11 (revised 2011) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used in pharmaceutical manufacturing and quality control. Published by the European Commission as part of EudraLex Volume 4.
How many controls does EU GMP Annex 11 have?
EU GMP Annex 11 contains 23 controls organized across 6 domains.
Where does EU GMP Annex 11 apply?
EU GMP Annex 11 is applicable in European Union (EMA/EC). Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.
What frameworks does EU GMP Annex 11 map to?
EU GMP Annex 11 has control-to-control mappings with 539 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.
How do I get started with EU GMP Annex 11 compliance?
Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.
How ready are you for EU GMP Annex 11 — Computerised Systems?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.