API 1164vs21 CFR Part 211 — Current Good Manufacturing Practice
See exactly how API 1164 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:
API 1164 maps to 21 CFR Part 211 — Current Good Manufacturing Practice with 17% coverage across 4 directly mapped controls. Analysis of 24 API 1164 controls identifies 20 compliance gaps — primarily concentrated in API 1164: Incident Response & Recovery.
Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
API 1164: Asset Identification & Governance(3 mappings)
API 1164: Supply Chain & Configuration(3 mappings)
Related Comparisons
Other API 1164 comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
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What are the key differences between API 1164 and 21 CFR Part 211 — Current Good Manufacturing Practice?
API 1164 has 24 controls across its framework, while 21 CFR Part 211 — Current Good Manufacturing Practice covers 57 controls. Direct mapping analysis identifies 4 overlapping controls (17% coverage). The frameworks diverge most significantly in API 1164: Incident Response & Recovery, where 5 API 1164 controls have no direct 21 CFR Part 211 — Current Good Manufacturing Practice equivalent.
How many controls map between API 1164 and 21 CFR Part 211 — Current Good Manufacturing Practice?
Of 24 total API 1164 controls, 4 map directly to 21 CFR Part 211 — Current Good Manufacturing Practice controls — representing 17% coverage. The remaining 20 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping API 1164 to 21 CFR Part 211 — Current Good Manufacturing Practice?
20 API 1164 controls have no direct equivalent in 21 CFR Part 211 — Current Good Manufacturing Practice. The highest concentration of gaps is in API 1164: Incident Response & Recovery with 5 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 API 1164 and 21 CFR Part 211 — Current Good Manufacturing Practice?
The domain with the highest gap count is API 1164: Incident Response & Recovery (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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