Annex 11 to EU GMP - Computerised SystemsvsISO 26262:2018 - Functional Safety for Road Vehicles
See exactly how Annex 11 to EU GMP - Computerised Systems controls map to ISO 26262:2018 - Functional Safety for Road Vehicles. 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 26262:2018 - Functional Safety for Road Vehicles with 24% coverage across 4 directly mapped controls. Analysis of 17 Annex 11 to EU GMP - Computerised Systems controls identifies 13 compliance gaps, primarily concentrated in Operational Phase - Data Management.
Source: TheArtOfService Knowledge Graph | 17 controls analysed | 686 frameworks | 310K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 2 domains. Sign up to explore all 310K+ mappings across 686 frameworks.
General Requirements (Annex 11)(3 mappings)
Operational Phase - Change and Configuration(3 mappings)
A Annex 11 to EU GMP - Computerised Systems to ISO 26262:2018 - Functional Safety for Road Vehicles crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which ISO 26262:2018 - Functional Safety for Road Vehicles 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 24% 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 26262:2018 - Functional Safety for Road Vehicles 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 26262:2018 - Functional Safety for Road Vehicles comparisons
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What are the key differences between Annex 11 to EU GMP - Computerised Systems and ISO 26262:2018 - Functional Safety for Road Vehicles?
Annex 11 to EU GMP - Computerised Systems has 17 controls across its framework, while ISO 26262:2018 - Functional Safety for Road Vehicles covers 69 controls. Direct mapping analysis identifies 4 overlapping controls (24% 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 26262:2018 - Functional Safety for Road Vehicles equivalent.
How many controls map between Annex 11 to EU GMP - Computerised Systems and ISO 26262:2018 - Functional Safety for Road Vehicles?
Of 17 total Annex 11 to EU GMP - Computerised Systems controls, 4 map directly to ISO 26262:2018 - Functional Safety for Road Vehicles controls, representing 24% coverage. The remaining 13 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 26262:2018 - Functional Safety for Road Vehicles?
13 Annex 11 to EU GMP - Computerised Systems controls have no direct equivalent in ISO 26262:2018 - Functional Safety for Road Vehicles. 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 26262:2018 - Functional Safety for Road Vehicles?
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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