API 1164vsFDA Quality Management System Regulation (QMSR)
See exactly how API 1164 controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
API 1164 maps to FDA Quality Management System Regulation (QMSR) with 17% coverage across 6 directly mapped controls. Analysis of 24 API 1164 controls identifies 39 compliance gaps — primarily concentrated in API 1164: Incident Response & Recovery.
Source: TheArtOfService Knowledge Graph | 24 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Risk(1 mappings)
API 1164: Asset Identification & Governance(1 mappings)
Regulatory(1 mappings)
API 1164: Supply Chain & Configuration(3 mappings)
Related Comparisons
Other API 1164 comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between API 1164 and FDA Quality Management System Regulation (QMSR)?
API 1164 has 24 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 6 overlapping controls (17% coverage). The frameworks diverge most significantly in API 1164: Incident Response & Recovery, where 5 API 1164 controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between API 1164 and FDA Quality Management System Regulation (QMSR)?
Of 24 total API 1164 controls, 6 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 17% coverage. The remaining 39 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping API 1164 to FDA Quality Management System Regulation (QMSR)?
39 API 1164 controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in API 1164: Incident Response & Recovery with 5 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 API 1164 and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is API 1164: Incident Response & Recovery (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.