FDA Quality Management System Regulation (QMSR)vsVoluntary Principles on Security and Human Rights (VPs)
See exactly how FDA Quality Management System Regulation (QMSR) controls map to Voluntary Principles on Security and Human Rights (VPs). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA Quality Management System Regulation (QMSR) maps to Voluntary Principles on Security and Human Rights (VPs) with 15% coverage across 2 directly mapped controls. Analysis of 13 FDA Quality Management System Regulation (QMSR) controls identifies 11 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 | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 2 of 2 mapped controls across 1 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)(2 mappings)
Related Comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
Other Voluntary Principles on Security and Human Rights (VPs) comparisons
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What are the key differences between FDA Quality Management System Regulation (QMSR) and Voluntary Principles on Security and Human Rights (VPs)?
FDA Quality Management System Regulation (QMSR) has 13 controls across its framework, while Voluntary Principles on Security and Human Rights (VPs) covers 35 controls. Direct mapping analysis identifies 2 overlapping controls (15% coverage). The frameworks diverge most significantly in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8), where 4 FDA Quality Management System Regulation (QMSR) controls have no direct Voluntary Principles on Security and Human Rights (VPs) equivalent.
How many controls map between FDA Quality Management System Regulation (QMSR) and Voluntary Principles on Security and Human Rights (VPs)?
Of 13 total FDA Quality Management System Regulation (QMSR) controls, 2 map directly to Voluntary Principles on Security and Human Rights (VPs) controls — representing 15% 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 FDA Quality Management System Regulation (QMSR) to Voluntary Principles on Security and Human Rights (VPs)?
11 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in Voluntary Principles on Security and Human Rights (VPs). The highest concentration of gaps is in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) with 4 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 Voluntary Principles on Security and Human Rights (VPs)?
The domain with the highest gap count is QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) (4 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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