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.

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

Frequently Asked Questions

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