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 18% coverage across 11 directly mapped controls. Analysis of 56 ISO/IEC 23894:2023 controls identifies 45 compliance gaps — primarily concentrated in Principles (Clause 4).
Source: TheArtOfService Knowledge Graph | 56 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 17 of 17 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 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 56 controls across its framework, while Annex 11 to EU GMP - Computerised Systems covers 17 controls. Direct mapping analysis identifies 11 overlapping controls (18% coverage). The frameworks diverge most significantly in Principles (Clause 4), where 8 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 56 total ISO/IEC 23894:2023 controls, 11 map directly to Annex 11 to EU GMP - Computerised Systems controls — representing 18% coverage. The remaining 45 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?
45 ISO/IEC 23894:2023 controls have no direct equivalent in Annex 11 to EU GMP - Computerised Systems. The highest concentration of gaps is in Principles (Clause 4) with 8 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 Principles (Clause 4) (8 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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