EU GMP Annex 11: Computerised SystemsvsFTC GLBA Safeguards Rule (16 CFR Part 314)
See exactly how EU GMP Annex 11: Computerised Systems controls map to FTC GLBA Safeguards Rule (16 CFR Part 314). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU GMP Annex 11: Computerised Systems maps to FTC GLBA Safeguards Rule (16 CFR Part 314) with 35% coverage across 8 directly mapped controls. Analysis of 23 EU GMP Annex 11: Computerised Systems controls identifies 15 compliance gaps — primarily concentrated in General Requirements.
Source: TheArtOfService Knowledge Graph | 23 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 16 of 16 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
General Requirements(7 mappings)
Operational Phase — Change and Configuration(3 mappings)
Operational Phase — Security and Access(4 mappings)
Operational Phase — Release and Continuity(1 mappings)
Operational Phase — Data Management(1 mappings)
Related Comparisons
Other EU GMP Annex 11: Computerised Systems comparisons
Other FTC GLBA Safeguards Rule (16 CFR Part 314) comparisons
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What are the key differences between EU GMP Annex 11: Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314)?
EU GMP Annex 11: Computerised Systems has 23 controls across its framework, while FTC GLBA Safeguards Rule (16 CFR Part 314) covers 36 controls. Direct mapping analysis identifies 8 overlapping controls (35% coverage). The frameworks diverge most significantly in General Requirements, where 6 EU GMP Annex 11: Computerised Systems controls have no direct FTC GLBA Safeguards Rule (16 CFR Part 314) equivalent.
How many controls map between EU GMP Annex 11: Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314)?
Of 23 total EU GMP Annex 11: Computerised Systems controls, 8 map directly to FTC GLBA Safeguards Rule (16 CFR Part 314) controls — representing 35% coverage. The remaining 15 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping EU GMP Annex 11: Computerised Systems to FTC GLBA Safeguards Rule (16 CFR Part 314)?
15 EU GMP Annex 11: Computerised Systems controls have no direct equivalent in FTC GLBA Safeguards Rule (16 CFR Part 314). The highest concentration of gaps is in General Requirements with 6 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between EU GMP Annex 11: Computerised Systems and FTC GLBA Safeguards Rule (16 CFR Part 314)?
The domain with the highest gap count is General Requirements (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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