EU GMP Annex 11: Computerised SystemsvsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how EU GMP Annex 11: Computerised Systems controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU GMP Annex 11: Computerised Systems maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 17% coverage across 4 directly mapped controls. Analysis of 23 EU GMP Annex 11: Computerised Systems controls identifies 19 compliance gaps — primarily concentrated in General Requirements.
Source: TheArtOfService Knowledge Graph | 23 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 16 of 16 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
General Requirements(9 mappings)
Operational Phase — Change and Configuration(7 mappings)
Related Comparisons
Other EU GMP Annex 11: Computerised Systems comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between EU GMP Annex 11: Computerised Systems and IEC 62304:2015 Medical Device Software Lifecycle Processes?
EU GMP Annex 11: Computerised Systems has 23 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 4 overlapping controls (17% coverage). The frameworks diverge most significantly in General Requirements, where 6 EU GMP Annex 11: Computerised Systems controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between EU GMP Annex 11: Computerised Systems and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 23 total EU GMP Annex 11: Computerised Systems controls, 4 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 17% coverage. The remaining 19 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping EU GMP Annex 11: Computerised Systems to IEC 62304:2015 Medical Device Software Lifecycle Processes?
19 EU GMP Annex 11: Computerised Systems controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in General Requirements with 6 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 EU GMP Annex 11: Computerised Systems and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is General Requirements (6 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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