21 CFR Part 211 - Current Good Manufacturing PracticevsISO/IEC 17025:2017 - General Requirements for Testing and Calibration
See exactly how 21 CFR Part 211 - Current Good Manufacturing Practice controls map to ISO/IEC 17025:2017 - General Requirements for Testing and Calibration. 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 17025:2017 - General Requirements for Testing and Calibration with 5% coverage across 4 directly mapped controls. Analysis of 78 21 CFR Part 211 - Current Good Manufacturing Practice controls identifies 74 compliance gaps — primarily concentrated in Subpart J - Records and Reports.
Source: TheArtOfService Knowledge Graph | 78 controls analysed | 686 frameworks | 309K+ cross-framework mappings
Control Mappings
Showing 5 of 5 mapped controls across 4 domains. Sign up to explore all 309K+ mappings across 686 frameworks.
Subpart A - General Provisions(2 mappings)
Subpart C - Buildings and Facilities(1 mappings)
Subpart F - Production and Process Controls(1 mappings)
Subpart I - Laboratory Controls(1 mappings)
Related Comparisons
Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons
Other ISO/IEC 17025:2017 - General Requirements for Testing and Calibration comparisons
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What are the key differences between 21 CFR Part 211 - Current Good Manufacturing Practice and ISO/IEC 17025:2017 - General Requirements for Testing and Calibration?
21 CFR Part 211 - Current Good Manufacturing Practice has 78 controls across its framework, while ISO/IEC 17025:2017 - General Requirements for Testing and Calibration covers 41 controls. Direct mapping analysis identifies 4 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 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration equivalent.
How many controls map between 21 CFR Part 211 - Current Good Manufacturing Practice and ISO/IEC 17025:2017 - General Requirements for Testing and Calibration?
Of 78 total 21 CFR Part 211 - Current Good Manufacturing Practice controls, 4 map directly to ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls — representing 5% coverage. The remaining 74 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 17025:2017 - General Requirements for Testing and Calibration?
74 21 CFR Part 211 - Current Good Manufacturing Practice controls have no direct equivalent in ISO/IEC 17025:2017 - General Requirements for Testing and Calibration. 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 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration?
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.
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