OtherEuropean Union (EMA/EC)
Annex 11 to EU GMP - Computerised Systems
Annex 11 (revised 2022) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used throughout the pharmaceutical lifecycle, including manufacturing, quality control, laboratory testing, and distribution. It addresses system validation, data integrity, security, change control, backup and recovery, and the overall lifecycle management of computerised systems.
Domains
General Requirements (Annex 11)
Operational Phase - Release and Continuity
Operational Phase - Security and Access
Operational Phase - Change and Configuration
Operational Phase - Data Management
Compare Annex 11 to EU GMP - Computerised Systems
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Annex 11 to EU GMP - Computerised Systems by Industry
Annex 11 to EU GMP - Computerised Systems for Healthcare→Annex 11 to EU GMP - Computerised Systems for Financial Services→Annex 11 to EU GMP - Computerised Systems for Technology→Annex 11 to EU GMP - Computerised Systems for Government→Annex 11 to EU GMP - Computerised Systems for Manufacturing→Annex 11 to EU GMP - Computerised Systems for Energy→Annex 11 to EU GMP - Computerised Systems for Retail→Annex 11 to EU GMP - Computerised Systems for Education→
Annex 11 to EU GMP - Computerised Systems by Role
Annex 11 to EU GMP - Computerised Systems for CISOs→Annex 11 to EU GMP - Computerised Systems for Compliance Officers→Annex 11 to EU GMP - Computerised Systems for Risk Managers→Annex 11 to EU GMP - Computerised Systems for IT Directors→Annex 11 to EU GMP - Computerised Systems for DPOs→Annex 11 to EU GMP - Computerised Systems for Auditors→
Frequently Asked Questions
What is Annex 11 to EU GMP - Computerised Systems?
Annex 11 (revised 2022) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used throughout the pharmaceutical lifecycle, including manufacturing, quality control, laboratory testing, and distribution. It addresses system validation, data integrity, security, change control, backup and recovery, and the overall lifecycle management of computerised systems.
How many controls does Annex 11 to EU GMP - Computerised Systems have?
Annex 11 to EU GMP - Computerised Systems contains 17 controls organized across 6 domains.
Where does Annex 11 to EU GMP - Computerised Systems apply?
Annex 11 to EU GMP - Computerised Systems is applicable in European Union (EMA/EC). Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.
What frameworks does Annex 11 to EU GMP - Computerised Systems map to?
Annex 11 to EU GMP - Computerised Systems has control-to-control mappings with 298 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.
How do I get started with Annex 11 to EU GMP - Computerised Systems 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 Annex 11 to EU GMP - Computerised Systems?
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