FDA 21 CFR Part 11vsGAMP 5 - Good Automated Manufacturing Practice
See exactly how FDA 21 CFR Part 11 controls map to GAMP 5 - Good Automated Manufacturing Practice. 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:
FDA 21 CFR Part 11 maps to GAMP 5 - Good Automated Manufacturing Practice with 23% coverage across 3 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 10 compliance gaps, primarily concentrated in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 1,016 frameworks | 316K+ cross-framework mappings
Control Mappings
Showing 5 of 5 control mappings across 2 domains. Sign up to explore all 316K+ mappings across 1,016 frameworks.
21 CFR Part 11 Subpart B - Electronic Records (§11.10 Closed Systems)(1 mappings)
21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(4 mappings)
A FDA 21 CFR Part 11 to GAMP 5 - Good Automated Manufacturing Practice crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which GAMP 5 - Good Automated Manufacturing Practice controls your existing FDA 21 CFR Part 11 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 23% in the header counts how many FDA 21 CFR Part 11 controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many GAMP 5 - Good Automated Manufacturing Practice 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 FDA 21 CFR Part 11 comparisons
Other GAMP 5 - Good Automated Manufacturing Practice comparisons
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What are the key differences between FDA 21 CFR Part 11 and GAMP 5 - Good Automated Manufacturing Practice?
FDA 21 CFR Part 11 has 13 controls across its framework, while GAMP 5 - Good Automated Manufacturing Practice covers 124 controls. Direct mapping analysis identifies 3 overlapping controls (23% coverage). The frameworks diverge most significantly in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)), where 2 FDA 21 CFR Part 11 controls have no direct GAMP 5 - Good Automated Manufacturing Practice equivalent.
How many controls map between FDA 21 CFR Part 11 and GAMP 5 - Good Automated Manufacturing Practice?
Of 13 total FDA 21 CFR Part 11 controls, 3 map directly to GAMP 5 - Good Automated Manufacturing Practice controls, representing 23% coverage. The remaining 10 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FDA 21 CFR Part 11 to GAMP 5 - Good Automated Manufacturing Practice?
10 FDA 21 CFR Part 11 controls have no direct equivalent in GAMP 5 - Good Automated Manufacturing Practice. The highest concentration of gaps is in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) with 2 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 FDA 21 CFR Part 11 and GAMP 5 - Good Automated Manufacturing Practice?
The domain with the highest gap count is 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) (2 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.