FDA Quality Management System Regulation (QMSR)vsAnnex 11 to EU GMP - Computerised Systems
See exactly how FDA Quality Management System Regulation (QMSR) controls map to Annex 11 to EU GMP - Computerised Systems. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA Quality Management System Regulation (QMSR) maps to Annex 11 to EU GMP - Computerised Systems 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 4 of 4 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)(4 mappings)
Related Comparisons
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Other Annex 11 to EU GMP - Computerised Systems comparisons
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What are the key differences between FDA Quality Management System Regulation (QMSR) and Annex 11 to EU GMP - Computerised Systems?
FDA Quality Management System Regulation (QMSR) has 13 controls across its framework, while Annex 11 to EU GMP - Computerised Systems covers 17 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 Annex 11 to EU GMP - Computerised Systems equivalent.
How many controls map between FDA Quality Management System Regulation (QMSR) and Annex 11 to EU GMP - Computerised Systems?
Of 13 total FDA Quality Management System Regulation (QMSR) controls, 2 map directly to Annex 11 to EU GMP - Computerised Systems 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 Annex 11 to EU GMP - Computerised Systems?
11 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in Annex 11 to EU GMP - Computerised Systems. 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 Annex 11 to EU GMP - Computerised Systems?
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.
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