21 CFR Part 211 - Current Good Manufacturing PracticevsAnnex 11 to EU GMP - Computerised Systems
See exactly how 21 CFR Part 211 - Current Good Manufacturing Practice controls map to Annex 11 to EU GMP - Computerised Systems. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
21 CFR Part 211 - Current Good Manufacturing Practice maps to Annex 11 to EU GMP - Computerised Systems with 3% coverage across 2 directly mapped controls. Analysis of 78 21 CFR Part 211 - Current Good Manufacturing Practice controls identifies 76 compliance gaps — primarily concentrated in Subpart F - Production and Process Controls.
Source: TheArtOfService Knowledge Graph | 78 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Subpart A - General Provisions(3 mappings)
Subpart J - Records and Reports(1 mappings)
Related Comparisons
Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons
Other Annex 11 to EU GMP - Computerised Systems comparisons
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What are the key differences between 21 CFR Part 211 - Current Good Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems?
21 CFR Part 211 - Current Good Manufacturing Practice has 78 controls across its framework, while Annex 11 to EU GMP - Computerised Systems covers 17 controls. Direct mapping analysis identifies 2 overlapping controls (3% coverage). The frameworks diverge most significantly in Subpart F - Production and Process Controls, where 8 21 CFR Part 211 - Current Good Manufacturing Practice controls have no direct Annex 11 to EU GMP - Computerised Systems equivalent.
How many controls map between 21 CFR Part 211 - Current Good Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems?
Of 78 total 21 CFR Part 211 - Current Good Manufacturing Practice controls, 2 map directly to Annex 11 to EU GMP - Computerised Systems controls — representing 3% coverage. The remaining 76 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping 21 CFR Part 211 - Current Good Manufacturing Practice to Annex 11 to EU GMP - Computerised Systems?
76 21 CFR Part 211 - Current Good Manufacturing Practice controls have no direct equivalent in Annex 11 to EU GMP - Computerised Systems. The highest concentration of gaps is in Subpart F - Production and Process Controls with 8 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 21 CFR Part 211 - Current Good Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems?
The domain with the highest gap count is Subpart F - Production and Process Controls (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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