ISO 27005vs21 CFR Part 211 - Current Good Manufacturing Practice
See exactly how ISO 27005 controls map to 21 CFR Part 211 - Current Good Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 27005 maps to 21 CFR Part 211 - Current Good Manufacturing Practice with 5% coverage across 1 directly mapped controls. Analysis of 40 ISO 27005 controls identifies 39 compliance gaps — primarily concentrated in Risk Assessment.
Source: TheArtOfService Knowledge Graph | 40 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 1 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
Risk Treatment(3 mappings)
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What are the key differences between ISO 27005 and 21 CFR Part 211 - Current Good Manufacturing Practice?
ISO 27005 has 40 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 78 controls. Direct mapping analysis identifies 1 overlapping controls (5% coverage). The frameworks diverge most significantly in Risk Assessment, where 8 ISO 27005 controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.
How many controls map between ISO 27005 and 21 CFR Part 211 - Current Good Manufacturing Practice?
Of 40 total ISO 27005 controls, 1 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls — representing 5% coverage. The remaining 39 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 27005 to 21 CFR Part 211 - Current Good Manufacturing Practice?
39 ISO 27005 controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. The highest concentration of gaps is in Risk Assessment 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 ISO 27005 and 21 CFR Part 211 - Current Good Manufacturing Practice?
The domain with the highest gap count is Risk Assessment (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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