FISMAvsFDA Quality Management System Regulation (QMSR)
See exactly how FISMA controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FISMA maps to FDA Quality Management System Regulation (QMSR) with 8% coverage across 1 directly mapped controls. Analysis of 12 FISMA controls identifies 11 compliance gaps — primarily concentrated in FISMA: Coordination with FedRAMP, EO 14028, OMB Memoranda and Status.
Source: TheArtOfService Knowledge Graph | 12 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.
FISMA: Operationalisation via NIST 800-53 RMF + 800-171 + FIPS 199/200(1 mappings)
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What are the key differences between FISMA and FDA Quality Management System Regulation (QMSR)?
FISMA has 12 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 1 overlapping controls (8% coverage). The frameworks diverge most significantly in FISMA: Coordination with FedRAMP, EO 14028, OMB Memoranda and Status, where 5 FISMA controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between FISMA and FDA Quality Management System Regulation (QMSR)?
Of 12 total FISMA controls, 1 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 8% coverage. The remaining 11 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FISMA to FDA Quality Management System Regulation (QMSR)?
11 FISMA controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in FISMA: Coordination with FedRAMP, EO 14028, OMB Memoranda and Status 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 FISMA and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is FISMA: Coordination with FedRAMP, EO 14028, OMB Memoranda and Status (5 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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