GAMP 5 - Good Automated Manufacturing Practice vs Annex 11 to EU GMP - Computerised Systems
What is the difference between GAMP 5 - Good Automated Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems?
GAMP 5 - Good Automated Manufacturing Practice is a risk management framework applying in International, with 11 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. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.
GAMP 5 - Good Automated Manufacturing Practice11 controls
Annex 11 to EU GMP - Computerised Systems17 controls
Questions people ask about GAMP 5 - Good Automated Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems
What is the difference between GAMP 5 - Good Automated Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems?
GAMP 5 - Good Automated Manufacturing Practice has 11 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 GAMP 5 - Good Automated Manufacturing Practice 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 GAMP 5 - Good Automated Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems so you can identify shared requirements and avoid duplicate effort.
How do GAMP 5 - Good Automated Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems controls map to each other?
Our platform maps controls between GAMP 5 - Good Automated Manufacturing Practice 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, GAMP 5 - Good Automated Manufacturing Practice 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.
GAMP 5 - Good Automated Manufacturing Practice vs OWASP DevSecOps Maturity Model (DSOMM)4 shared controlsGAMP 5 - Good Automated Manufacturing Practice vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements4 shared controlsGAMP 5 - Good Automated Manufacturing Practice vs DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)4 shared controlsAnnex 11 to EU GMP - Computerised Systems vs FDA 21 CFR Part 1113 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 controls
See all control mappings with interactive gap analysis
Explore the complete mapping between GAMP 5 - Good Automated Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.