ISO/IEC 23894:2023vsAnnex 11 to EU GMP - Computerised Systems
See exactly how ISO/IEC 23894:2023 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:
ISO/IEC 23894:2023 maps to Annex 11 to EU GMP - Computerised Systems with 13% coverage across 11 directly mapped controls. Analysis of 85 ISO/IEC 23894:2023 controls identifies 74 compliance gaps — primarily concentrated in Risk management process – ISO/IEC 23894:2023.
Source: TheArtOfService Knowledge Graph | 85 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 17 of 17 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Annex Guidance(1 mappings)
Scope, Terms and References (Clauses 1-3)(6 mappings)
Framework (Clause 5)(3 mappings)
Process (Clause 6)(6 mappings)
AI-Specific Risk Sources (Annex A)(1 mappings)
Related Comparisons
Other ISO/IEC 23894:2023 comparisons
Other Annex 11 to EU GMP - Computerised Systems comparisons
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What are the key differences between ISO/IEC 23894:2023 and Annex 11 to EU GMP - Computerised Systems?
ISO/IEC 23894:2023 has 85 controls across its framework, while Annex 11 to EU GMP - Computerised Systems covers 17 controls. Direct mapping analysis identifies 11 overlapping controls (13% coverage). The frameworks diverge most significantly in Risk management process – ISO/IEC 23894:2023, where 17 ISO/IEC 23894:2023 controls have no direct Annex 11 to EU GMP - Computerised Systems equivalent.
How many controls map between ISO/IEC 23894:2023 and Annex 11 to EU GMP - Computerised Systems?
Of 85 total ISO/IEC 23894:2023 controls, 11 map directly to Annex 11 to EU GMP - Computerised Systems controls — representing 13% coverage. The remaining 74 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 23894:2023 to Annex 11 to EU GMP - Computerised Systems?
74 ISO/IEC 23894:2023 controls have no direct equivalent in Annex 11 to EU GMP - Computerised Systems. The highest concentration of gaps is in Risk management process – ISO/IEC 23894:2023 with 17 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 ISO/IEC 23894:2023 and Annex 11 to EU GMP - Computerised Systems?
The domain with the highest gap count is Risk management process – ISO/IEC 23894:2023 (17 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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