Annex 11 to EU GMP - Computerised Systems vs FTC GLBA Safeguards Rule (16 CFR Part 314)
What is the difference between Annex 11 to EU GMP - Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314)?
Annex 11 to EU GMP - Computerised Systems is a other framework applying in the European Union (EMA/EC), with 17 controls across 6 domains. FTC GLBA Safeguards Rule (16 CFR Part 314) is a other framework applying in the United States (FTC), with 11 controls across 7 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.
Annex 11 to EU GMP - Computerised Systems17 controls
FTC GLBA Safeguards Rule (16 CFR Part 314)11 controls
Questions people ask about Annex 11 to EU GMP - Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314)
What is the difference between Annex 11 to EU GMP - Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314)?
Annex 11 to EU GMP - Computerised Systems has 17 controls while FTC GLBA Safeguards Rule (16 CFR Part 314) has 11 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 Annex 11 to EU GMP - Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314)?
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 Annex 11 to EU GMP - Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314) so you can identify shared requirements and avoid duplicate effort.
How do Annex 11 to EU GMP - Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314) controls map to each other?
Our platform maps controls between Annex 11 to EU GMP - Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314) 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, Annex 11 to EU GMP - Computerised Systems or FTC GLBA Safeguards Rule (16 CFR Part 314)?
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.
Annex 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 controlsFTC GLBA Safeguards Rule (16 CFR Part 314) vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)6 shared controlsFTC GLBA Safeguards Rule (16 CFR Part 314) vs UAE Virtual Asset Regulatory Authority (VARA) Regulations6 shared controlsFTC GLBA Safeguards Rule (16 CFR Part 314) vs Privacy Act 1988 (Australia)6 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between Annex 11 to EU GMP - Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314) on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.