Annex 11 to EU GMP - Computerised Systems
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. It comprises 17 controls organised across 6 domains, and applies in the European Union (EMA/EC).
How Annex 11 to EU GMP - Computerised Systems maps to other frameworks
All 17 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 6 domains Annex 11 to EU GMP - Computerised Systems groups its controls into
Frameworks that share controls with Annex 11 to EU GMP - Computerised Systems
Each of these has at least one control mapped to a control in Annex 11 to EU GMP - Computerised Systems. The number is how many Annex 11 to EU GMP - Computerised Systems controls are shared, counted from the mapping graph.
FDA 21 CFR Part 11
13 shared controlsNIST SP 800-53 Rev 5
9 shared controlsSouth Korea ISMS-P
8 shared controlsNIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
7 shared controlsGAMP 5 - Good Automated Manufacturing Practice
7 shared controlsFTC GLBA Safeguards Rule (16 CFR Part 314)
7 shared controlsFedRAMP Rev 5
7 shared controlsProtective Security Policy Framework (PSPF) Release 2024
6 shared controlsImplementation guides for frameworks that overlap Annex 11 to EU GMP - Computerised Systems
Where Annex 11 to EU GMP - Computerised Systems overlaps with the standards you already hold
What Annex 11 to EU GMP - Computerised Systems means in your sector
What Annex 11 to EU GMP - Computerised Systems means for your job
Questions people ask about Annex 11 to EU GMP - Computerised Systems
What is Annex 11 to EU GMP - Computerised Systems?
How many controls does Annex 11 to EU GMP - Computerised Systems have?
Where does Annex 11 to EU GMP - Computerised Systems apply?
What frameworks does Annex 11 to EU GMP - Computerised Systems map to?
How do I get started with Annex 11 to EU GMP - Computerised Systems compliance?
Query Annex 11 to EU GMP - Computerised Systems programmatically
Annex 11 to EU GMP - Computerised Systems, its 17 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
Annex 11 to EU GMP - Computerised Systems API reference and MCP config →What Annex 11 to EU GMP - Computerised Systems requires, control by control
Each page carries the requirement text for one Annex 11 to EU GMP - Computerised Systems control and what an assessor expects to see as evidence.
How ready are you for Annex 11 to EU GMP - Computerised Systems?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.