FDA 21 CFR Part 11 vs Annex 11 to EU GMP - Computerised Systems
What is the difference between FDA 21 CFR Part 11 and Annex 11 to EU GMP - Computerised Systems?
FDA 21 CFR Part 11 is a other framework applying in the United States, with 13 controls across 7 domains. Annex 11 to EU GMP - Computerised Systems is a other framework applying in the European Union (EMA/EC), with 17 controls across 6 domains. Both govern the same subject, so their requirements overlap; the mapping below shows which controls carry across and which are asked for by only one of them.
FDA 21 CFR Part 1113 controls
Annex 11 to EU GMP - Computerised Systems17 controls
Questions people ask about FDA 21 CFR Part 11 and Annex 11 to EU GMP - Computerised Systems
What is the difference between FDA 21 CFR Part 11 and Annex 11 to EU GMP - Computerised Systems?
FDA 21 CFR Part 11 has 13 controls while Annex 11 to EU GMP - Computerised Systems has 17 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.
Do I need both FDA 21 CFR Part 11 and Annex 11 to EU GMP - Computerised Systems?
Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between FDA 21 CFR Part 11 and Annex 11 to EU GMP - Computerised Systems so you can identify shared requirements and avoid duplicate effort.
How do FDA 21 CFR Part 11 and Annex 11 to EU GMP - Computerised Systems controls map to each other?
Our platform maps controls between FDA 21 CFR Part 11 and Annex 11 to EU GMP - Computerised Systems at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.
Which framework should I implement first, FDA 21 CFR Part 11 or Annex 11 to EU GMP - Computerised Systems?
The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.
Each framework on its own
Comparisons people read next
Each of these compares one of the two standards above against another it shares controls with.
FDA 21 CFR Part 11 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)7 shared controlsFDA 21 CFR Part 11 vs US Consumer Product Safety Commission (CPSC) - Connected Product Safety6 shared controlsFDA 21 CFR Part 11 vs ASD Strategies to Mitigate Cyber Security Incidents6 shared controlsAnnex 11 to EU GMP - Computerised Systems vs NIST SP 800-53 Rev 59 shared controlsAnnex 11 to EU GMP - Computerised Systems vs South Korea ISMS-P8 shared controlsAnnex 11 to EU GMP - Computerised Systems vs NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security7 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between FDA 21 CFR Part 11 and Annex 11 to EU GMP - Computerised Systems on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.