21 CFR Part 211 — Current Good Manufacturing PracticevsFDA Quality Management System Regulation (QMSR)
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to FDA Quality Management System Regulation (QMSR). 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 FDA Quality Management System Regulation (QMSR) with 14% coverage across 8 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 49 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 11 of 11 mapped controls across 6 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart A — General Provisions(1 mappings)
Subpart C — Buildings and Facilities(2 mappings)
Subpart F — Production and Process Controls(2 mappings)
Subpart G — Packaging and Labeling Control(3 mappings)
Subpart I — Laboratory Controls(2 mappings)
Subpart J — Records and Reports(1 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and FDA Quality Management System Regulation (QMSR)?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 34 controls. Direct mapping analysis identifies 8 overlapping controls (14% 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 FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and FDA Quality Management System Regulation (QMSR)?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 8 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 14% coverage. The remaining 49 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 FDA Quality Management System Regulation (QMSR)?
49 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). 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 FDA Quality Management System Regulation (QMSR)?
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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