GAMP 5 - Good Automated Manufacturing PracticevsFDA 21 CFR Part 11
See exactly how GAMP 5 - Good Automated Manufacturing Practice 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:
GAMP 5 - Good Automated Manufacturing Practice maps to FDA 21 CFR Part 11 with 4% coverage across 5 directly mapped controls. Analysis of 124 GAMP 5 - Good Automated Manufacturing Practice controls identifies 119 compliance gaps, primarily concentrated in Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice.
Source: TheArtOfService Knowledge Graph | 124 controls analysed | 1,016 frameworks | 316K+ cross-framework mappings
Control Mappings
Showing 5 of 5 control mappings across 4 domains. Sign up to explore all 316K+ mappings across 1,016 frameworks.
Chapter 2: Key concepts (product and process understanding, life cycle within a QMS, scalable activities, science-based QRM, leveraging suppliers) – GAMP 5 - Good Automated Manufacturing Practice(1 mappings)
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice(1 mappings)
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice(1 mappings)
Special interest appendices S1 to S6 (ASTM E2500, electronic production records, end user applications, patch management, organizational change) – GAMP 5 - Good Automated Manufacturing Practice(2 mappings)
A GAMP 5 - Good Automated Manufacturing Practice 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 GAMP 5 - Good Automated Manufacturing Practice 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 4% in the header counts how many GAMP 5 - Good Automated Manufacturing Practice 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 GAMP 5 - Good Automated Manufacturing Practice comparisons
Other FDA 21 CFR Part 11 comparisons
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What are the key differences between GAMP 5 - Good Automated Manufacturing Practice and FDA 21 CFR Part 11?
GAMP 5 - Good Automated Manufacturing Practice has 124 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 5 overlapping controls (4% coverage). The frameworks diverge most significantly in Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice, where 19 GAMP 5 - Good Automated Manufacturing Practice controls have no direct FDA 21 CFR Part 11 equivalent.
How many controls map between GAMP 5 - Good Automated Manufacturing Practice and FDA 21 CFR Part 11?
Of 124 total GAMP 5 - Good Automated Manufacturing Practice controls, 5 map directly to FDA 21 CFR Part 11 controls, representing 4% coverage. The remaining 119 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping GAMP 5 - Good Automated Manufacturing Practice to FDA 21 CFR Part 11?
119 GAMP 5 - Good Automated Manufacturing Practice controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice with 19 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 GAMP 5 - Good Automated Manufacturing Practice and FDA 21 CFR Part 11?
The domain with the highest gap count is Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice (19 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.