GAMP 5 - Good Automated Manufacturing PracticevsISO 13485:2016
See exactly how GAMP 5 - Good Automated Manufacturing Practice controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
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According to the TheArtOfService Compliance Knowledge Graph:
GAMP 5 - Good Automated Manufacturing Practice maps to ISO 13485:2016 with 26% coverage across 32 directly mapped controls. Analysis of 124 GAMP 5 - Good Automated Manufacturing Practice controls identifies 92 compliance gaps, primarily concentrated in Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice.
Source: TheArtOfService Knowledge Graph | 124 controls analysed | 1,016 frameworks | 316K+ cross-framework mappings
Control Mappings
Showing 20 of 32 control mappings across 9 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 3: Life cycle approach (life cycle, specification and verification, validation framework, critical thinking) – GAMP 5 - Good Automated Manufacturing Practice(1 mappings)
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice(6 mappings)
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice(7 mappings)
Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice(5 mappings)
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A GAMP 5 - Good Automated Manufacturing Practice to ISO 13485:2016 crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which ISO 13485:2016 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 26% 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 ISO 13485:2016 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
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Other ISO 13485:2016 comparisons
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What are the key differences between GAMP 5 - Good Automated Manufacturing Practice and ISO 13485:2016?
GAMP 5 - Good Automated Manufacturing Practice has 124 controls across its framework, while ISO 13485:2016 covers 67 controls. Direct mapping analysis identifies 32 overlapping controls (26% coverage). The frameworks diverge most significantly in Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice, where 14 GAMP 5 - Good Automated Manufacturing Practice controls have no direct ISO 13485:2016 equivalent.
How many controls map between GAMP 5 - Good Automated Manufacturing Practice and ISO 13485:2016?
Of 124 total GAMP 5 - Good Automated Manufacturing Practice controls, 32 map directly to ISO 13485:2016 controls, representing 26% coverage. The remaining 92 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 ISO 13485:2016?
92 GAMP 5 - Good Automated Manufacturing Practice controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice with 14 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 ISO 13485:2016?
The domain with the highest gap count is Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice (14 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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