21 CFR Part 211 — Current Good Manufacturing PracticevsCOSO Internal Control — Integrated Framework (2013)
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to COSO Internal Control — Integrated Framework (2013). 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 COSO Internal Control — Integrated Framework (2013) with 5% coverage across 3 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 54 compliance gaps — primarily concentrated in Subpart J — Records and Reports.
Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 1 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart G — Packaging and Labeling Control(3 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
Other COSO Internal Control — Integrated Framework (2013) comparisons
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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and COSO Internal Control — Integrated Framework (2013)?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while COSO Internal Control — Integrated Framework (2013) covers 31 controls. Direct mapping analysis identifies 3 overlapping controls (5% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 9 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct COSO Internal Control — Integrated Framework (2013) equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and COSO Internal Control — Integrated Framework (2013)?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 3 map directly to COSO Internal Control — Integrated Framework (2013) controls — representing 5% coverage. The remaining 54 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 COSO Internal Control — Integrated Framework (2013)?
54 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in COSO Internal Control — Integrated Framework (2013). The highest concentration of gaps is in Subpart J — Records and Reports with 9 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 COSO Internal Control — Integrated Framework (2013)?
The domain with the highest gap count is Subpart J — Records and Reports (9 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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