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.
Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.
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 | 692 frameworks | 306K+ cross-framework mappings
Control Mappings
Showing 13 of 13 mapped controls across 3 domains. Sign up to explore all 306K+ mappings across 692 frameworks.
General Requirements (Annex 11)(9 mappings)
Operational Phase - Change and Configuration(3 mappings)
Operational Phase - Release and Continuity(1 mappings)
A Annex 11 to EU GMP - Computerised Systems to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls your existing Annex 11 to EU GMP - Computerised Systems work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
- Every evidenced control, with the reasoning behind it
- Every gap, with what it requires
- Its level of review stated plainly, not a bare number
Why this page shows two different percentages. The 29% in the header counts how many Annex 11 to EU GMP - Computerised Systems controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.
A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.
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 39 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.
Related Resources
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