FDA 21 CFR Part 11vsFDA Quality Management System Regulation (QMSR)
See exactly how FDA 21 CFR Part 11 controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to FDA Quality Management System Regulation (QMSR) with 31% coverage across 4 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 9 compliance gaps — primarily concentrated in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
21 CFR Part 11 Subpart B - Electronic Records (§11.10 Closed Systems)(1 mappings)
21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(5 mappings)
Related Comparisons
Other FDA 21 CFR Part 11 comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between FDA 21 CFR Part 11 and FDA Quality Management System Regulation (QMSR)?
FDA 21 CFR Part 11 has 13 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 4 overlapping controls (31% coverage). The frameworks diverge most significantly in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions), where 2 FDA 21 CFR Part 11 controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between FDA 21 CFR Part 11 and FDA Quality Management System Regulation (QMSR)?
Of 13 total FDA 21 CFR Part 11 controls, 4 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 31% coverage. The remaining 9 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FDA 21 CFR Part 11 to FDA Quality Management System Regulation (QMSR)?
9 FDA 21 CFR Part 11 controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions) with 2 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 FDA 21 CFR Part 11 and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions) (2 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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