Annex 11 to EU GMP - Computerised SystemsvsISO/IEC 23894:2023
See exactly how Annex 11 to EU GMP - Computerised Systems controls map to ISO/IEC 23894:2023. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
Annex 11 to EU GMP - Computerised Systems maps to ISO/IEC 23894:2023 with 24% coverage across 5 directly mapped controls. Analysis of 17 Annex 11 to EU GMP - Computerised Systems controls identifies 12 compliance gaps — primarily concentrated in Operational Phase - Data Management.
Source: TheArtOfService Knowledge Graph | 17 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 17 of 17 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
General Requirements (Annex 11)(13 mappings)
Operational Phase - Change and Configuration(3 mappings)
Operational Phase - Data Management(1 mappings)
Related Comparisons
Other Annex 11 to EU GMP - Computerised Systems comparisons
Other ISO/IEC 23894:2023 comparisons
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What are the key differences between Annex 11 to EU GMP - Computerised Systems and ISO/IEC 23894:2023?
Annex 11 to EU GMP - Computerised Systems has 17 controls across its framework, while ISO/IEC 23894:2023 covers 56 controls. Direct mapping analysis identifies 5 overlapping controls (24% coverage). The frameworks diverge most significantly in Operational Phase - Data Management, where 4 Annex 11 to EU GMP - Computerised Systems controls have no direct ISO/IEC 23894:2023 equivalent.
How many controls map between Annex 11 to EU GMP - Computerised Systems and ISO/IEC 23894:2023?
Of 17 total Annex 11 to EU GMP - Computerised Systems controls, 5 map directly to ISO/IEC 23894:2023 controls — representing 24% coverage. The remaining 12 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping Annex 11 to EU GMP - Computerised Systems to ISO/IEC 23894:2023?
12 Annex 11 to EU GMP - Computerised Systems controls have no direct equivalent in ISO/IEC 23894:2023. The highest concentration of gaps is in Operational Phase - Data Management 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 Annex 11 to EU GMP - Computerised Systems and ISO/IEC 23894:2023?
The domain with the highest gap count is Operational Phase - Data Management (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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