COBIT 2019vsFDA Quality Management System Regulation (QMSR)
See exactly how COBIT 2019 controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
COBIT 2019 maps to FDA Quality Management System Regulation (QMSR) with 3% coverage across 2 directly mapped controls. Analysis of 68 COBIT 2019 controls identifies 66 compliance gaps — primarily concentrated in APO - Align, Plan and Organize.
Source: TheArtOfService Knowledge Graph | 68 controls analysed | 726 frameworks | 455K+ cross-framework mappings
Control Mappings
Showing 2 of 2 mapped controls across 1 domains. Sign up to explore all 455K+ mappings across 726 frameworks.
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Related Comparisons
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What are the key differences between COBIT 2019 and FDA Quality Management System Regulation (QMSR)?
COBIT 2019 has 68 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 54 controls. Direct mapping analysis identifies 2 overlapping controls (3% coverage). The frameworks diverge most significantly in APO - Align, Plan and Organize, where 14 COBIT 2019 controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between COBIT 2019 and FDA Quality Management System Regulation (QMSR)?
Of 68 total COBIT 2019 controls, 2 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 3% coverage. The remaining 66 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping COBIT 2019 to FDA Quality Management System Regulation (QMSR)?
66 COBIT 2019 controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in APO - Align, Plan and Organize with 14 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 COBIT 2019 and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is APO - Align, Plan and Organize (14 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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