Annex 11 to EU GMP - Computerised SystemsvsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
See exactly how Annex 11 to EU GMP - Computerised Systems controls map to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. 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 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 29% 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 | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 19 of 19 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
General Requirements (Annex 11)(13 mappings)
Operational Phase - Change and Configuration(5 mappings)
Operational Phase - Release and Continuity(1 mappings)
Related Comparisons
Other Annex 11 to EU GMP - Computerised Systems comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
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What are the key differences between Annex 11 to EU GMP - Computerised Systems and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
Annex 11 to EU GMP - Computerised Systems has 17 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 77 controls. Direct mapping analysis identifies 5 overlapping controls (29% coverage). The frameworks diverge most significantly in Operational Phase - Data Management, where 5 Annex 11 to EU GMP - Computerised Systems controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between Annex 11 to EU GMP - Computerised Systems and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
Of 17 total Annex 11 to EU GMP - Computerised Systems controls, 5 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 29% 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 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
12 Annex 11 to EU GMP - Computerised Systems controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Operational Phase - Data Management with 5 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 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is Operational Phase - Data Management (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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