Annex 11 to EU GMP - Computerised SystemsvsFDA 21 CFR Part 11
See exactly how Annex 11 to EU GMP - Computerised Systems controls map to FDA 21 CFR Part 11. 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 FDA 21 CFR Part 11 with 76% coverage across 13 directly mapped controls. Analysis of 17 Annex 11 to EU GMP - Computerised Systems controls identifies 4 compliance gaps, primarily concentrated in General Requirements (Annex 11).
Source: TheArtOfService Knowledge Graph | 17 controls analysed | 686 frameworks | 310K+ cross-framework mappings
Control Mappings
Showing 16 of 16 mapped controls across 6 domains. Sign up to explore all 310K+ mappings across 686 frameworks.
General Requirements (Annex 11)(2 mappings)
Operational Phase - Change and Configuration(1 mappings)
Operational Phase - Security and Access(5 mappings)
Operational Phase - Release and Continuity(2 mappings)
Project Phase(1 mappings)
Operational Phase - Data Management(5 mappings)
A Annex 11 to EU GMP - Computerised Systems to FDA 21 CFR Part 11 crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which FDA 21 CFR Part 11 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 76% 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 FDA 21 CFR Part 11 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 FDA 21 CFR Part 11 comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 686 frameworks, at a fraction of consulting costs.
Free
- ✓ 686 framework browser
- ✓ Cross-framework mappings (310K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between Annex 11 to EU GMP - Computerised Systems and FDA 21 CFR Part 11?
Annex 11 to EU GMP - Computerised Systems has 17 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 13 overlapping controls (76% coverage). The frameworks diverge most significantly in General Requirements (Annex 11), where 1 Annex 11 to EU GMP - Computerised Systems controls have no direct FDA 21 CFR Part 11 equivalent.
How many controls map between Annex 11 to EU GMP - Computerised Systems and FDA 21 CFR Part 11?
Of 17 total Annex 11 to EU GMP - Computerised Systems controls, 13 map directly to FDA 21 CFR Part 11 controls, representing 76% coverage. The remaining 4 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 FDA 21 CFR Part 11?
4 Annex 11 to EU GMP - Computerised Systems controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in General Requirements (Annex 11) with 1 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 FDA 21 CFR Part 11?
The domain with the highest gap count is General Requirements (Annex 11) (1 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.