Annex 11 to EU GMP - Computerised SystemsvsNIST SP 800-66
See exactly how Annex 11 to EU GMP - Computerised Systems controls map to NIST SP 800-66. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
Annex 11 to EU GMP - Computerised Systems maps to NIST SP 800-66 with 18% coverage across 3 directly mapped controls. Analysis of 17 Annex 11 to EU GMP - Computerised Systems controls identifies 14 compliance gaps — primarily concentrated in Operational Phase - Data Management.
Source: TheArtOfService Knowledge Graph | 17 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 5 of 5 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
General Requirements (Annex 11)(1 mappings)
Operational Phase - Security and Access(3 mappings)
Operational Phase - Data Management(1 mappings)
Related Comparisons
Other Annex 11 to EU GMP - Computerised Systems comparisons
Other NIST SP 800-66 comparisons
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What are the key differences between Annex 11 to EU GMP - Computerised Systems and NIST SP 800-66?
Annex 11 to EU GMP - Computerised Systems has 17 controls across its framework, while NIST SP 800-66 covers 8 controls. Direct mapping analysis identifies 3 overlapping controls (18% coverage). The frameworks diverge most significantly in Operational Phase - Data Management, where 4 Annex 11 to EU GMP - Computerised Systems controls have no direct NIST SP 800-66 equivalent.
How many controls map between Annex 11 to EU GMP - Computerised Systems and NIST SP 800-66?
Of 17 total Annex 11 to EU GMP - Computerised Systems controls, 3 map directly to NIST SP 800-66 controls — representing 18% coverage. The remaining 14 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping Annex 11 to EU GMP - Computerised Systems to NIST SP 800-66?
14 Annex 11 to EU GMP - Computerised Systems controls have no direct equivalent in NIST SP 800-66. The highest concentration of gaps is in Operational Phase - Data Management with 4 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 Annex 11 to EU GMP - Computerised Systems and NIST SP 800-66?
The domain with the highest gap count is Operational Phase - Data Management (4 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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