21 CFR Part 211 - Current Good Manufacturing PracticevsISO/IEC 27003:2017
See exactly how 21 CFR Part 211 - Current Good Manufacturing Practice controls map to ISO/IEC 27003:2017. 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 ISO/IEC 27003:2017 with 6% coverage across 5 directly mapped controls. Analysis of 78 21 CFR Part 211 - Current Good Manufacturing Practice controls identifies 73 compliance gaps — primarily concentrated in Subpart J - Records and Reports.
Source: TheArtOfService Knowledge Graph | 78 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 7 of 7 mapped controls across 5 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
Subpart A - General Provisions(1 mappings)
Subpart C - Buildings and Facilities(1 mappings)
Subpart F - Production and Process Controls(1 mappings)
Subpart I - Laboratory Controls(1 mappings)
Subpart J - Records and Reports(3 mappings)
Related Comparisons
Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons
Other ISO/IEC 27003:2017 comparisons
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What are the key differences between 21 CFR Part 211 - Current Good Manufacturing Practice and ISO/IEC 27003:2017?
21 CFR Part 211 - Current Good Manufacturing Practice has 78 controls across its framework, while ISO/IEC 27003:2017 covers 72 controls. Direct mapping analysis identifies 5 overlapping controls (6% coverage). The frameworks diverge most significantly in Subpart J - Records and Reports, where 8 21 CFR Part 211 - Current Good Manufacturing Practice controls have no direct ISO/IEC 27003:2017 equivalent.
How many controls map between 21 CFR Part 211 - Current Good Manufacturing Practice and ISO/IEC 27003:2017?
Of 78 total 21 CFR Part 211 - Current Good Manufacturing Practice controls, 5 map directly to ISO/IEC 27003:2017 controls — representing 6% coverage. The remaining 73 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 ISO/IEC 27003:2017?
73 21 CFR Part 211 - Current Good Manufacturing Practice controls have no direct equivalent in ISO/IEC 27003:2017. The highest concentration of gaps is in Subpart J - Records and Reports 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 ISO/IEC 27003:2017?
The domain with the highest gap count is Subpart J - Records and Reports (8 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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