FDA Quality Management System Regulation (QMSR)vsFedRAMP High
See exactly how FDA Quality Management System Regulation (QMSR) controls map to FedRAMP High. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA Quality Management System Regulation (QMSR) maps to FedRAMP High with 8% coverage across 1 directly mapped controls. Analysis of 13 FDA Quality Management System Regulation (QMSR) controls identifies 12 compliance gaps — primarily concentrated in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)(1 mappings)
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What are the key differences between FDA Quality Management System Regulation (QMSR) and FedRAMP High?
FDA Quality Management System Regulation (QMSR) has 13 controls across its framework, while FedRAMP High covers 417 controls. Direct mapping analysis identifies 1 overlapping controls (8% coverage). The frameworks diverge most significantly in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8), where 5 FDA Quality Management System Regulation (QMSR) controls have no direct FedRAMP High equivalent.
How many controls map between FDA Quality Management System Regulation (QMSR) and FedRAMP High?
Of 13 total FDA Quality Management System Regulation (QMSR) controls, 1 map directly to FedRAMP High controls — representing 8% coverage. The remaining 12 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FDA Quality Management System Regulation (QMSR) to FedRAMP High?
12 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in FedRAMP High. The highest concentration of gaps is in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) 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 FDA Quality Management System Regulation (QMSR) and FedRAMP High?
The domain with the highest gap count is QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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