MDS2 (Medical Device)vsAnnex 11 to EU GMP - Computerised Systems
See exactly how MDS2 (Medical Device) 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:
MDS2 (Medical Device) maps to Annex 11 to EU GMP - Computerised Systems with 50% coverage across 4 directly mapped controls. Analysis of 8 MDS2 (Medical Device) controls identifies 4 compliance gaps — primarily concentrated in Roadmap Third Party Security Guidance and Vulnerability Disclosure - MDS2.
Source: TheArtOfService Knowledge Graph | 8 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 5 of 5 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Audit Logging Integrity and Cybersecurity Risk - MDS2(2 mappings)
PHI Data Handling Storage and Transmission - MDS2(1 mappings)
Authentication and Authorization - MDS2(1 mappings)
Physical Security Workstation Disposal and Backup - MDS2(1 mappings)
Related Comparisons
Other MDS2 (Medical Device) comparisons
Other Annex 11 to EU GMP - Computerised Systems comparisons
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What are the key differences between MDS2 (Medical Device) and Annex 11 to EU GMP - Computerised Systems?
MDS2 (Medical Device) has 8 controls across its framework, while Annex 11 to EU GMP - Computerised Systems covers 17 controls. Direct mapping analysis identifies 4 overlapping controls (50% coverage). The frameworks diverge most significantly in Roadmap Third Party Security Guidance and Vulnerability Disclosure - MDS2, where 1 MDS2 (Medical Device) controls have no direct Annex 11 to EU GMP - Computerised Systems equivalent.
How many controls map between MDS2 (Medical Device) and Annex 11 to EU GMP - Computerised Systems?
Of 8 total MDS2 (Medical Device) controls, 4 map directly to Annex 11 to EU GMP - Computerised Systems controls — representing 50% coverage. The remaining 4 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping MDS2 (Medical Device) to Annex 11 to EU GMP - Computerised Systems?
4 MDS2 (Medical Device) controls have no direct equivalent in Annex 11 to EU GMP - Computerised Systems. The highest concentration of gaps is in Roadmap Third Party Security Guidance and Vulnerability Disclosure - MDS2 with 1 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 MDS2 (Medical Device) and Annex 11 to EU GMP - Computerised Systems?
The domain with the highest gap count is Roadmap Third Party Security Guidance and Vulnerability Disclosure - MDS2 (1 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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