GAMP 5 - Good Automated Manufacturing PracticevsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how GAMP 5 - Good Automated Manufacturing Practice controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. 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 IEC 62304:2015 Medical Device Software Lifecycle Processes with 15% coverage across 19 directly mapped controls. Analysis of 124 GAMP 5 - Good Automated Manufacturing Practice controls identifies 105 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 19 of 19 control mappings across 6 domains. Sign up to explore all 316K+ mappings across 1,016 frameworks.
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice(3 mappings)
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice(3 mappings)
Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice(5 mappings)
Chapter 8: Efficiency improvements – GAMP 5 - Good Automated Manufacturing Practice(2 mappings)
Development appendices D1 to D11 (requirements, configuration and design, software, testing, system descriptions, data migration, Agile, tools, distributed ledgers, AI and ML) – GAMP 5 - Good Automated Manufacturing Practice(5 mappings)
Management appendices M1 to M12 (planning, supplier assessment, QRM, categories, design review and traceability, quality planning, reporting, project change, documentation, retirement, infrastructure, critical thinking) – GAMP 5 - Good Automated Manufacturing Practice(1 mappings)
A GAMP 5 - Good Automated Manufacturing Practice to IEC 62304:2015 Medical Device Software Lifecycle Processes crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which IEC 62304:2015 Medical Device Software Lifecycle Processes 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 15% 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 IEC 62304:2015 Medical Device Software Lifecycle Processes 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 IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between GAMP 5 - Good Automated Manufacturing Practice and IEC 62304:2015 Medical Device Software Lifecycle Processes?
GAMP 5 - Good Automated Manufacturing Practice has 124 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 132 controls. Direct mapping analysis identifies 19 overlapping controls (15% coverage). The frameworks diverge most significantly in Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice, where 17 GAMP 5 - Good Automated Manufacturing Practice controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between GAMP 5 - Good Automated Manufacturing Practice and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 124 total GAMP 5 - Good Automated Manufacturing Practice controls, 19 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls, representing 15% coverage. The remaining 105 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 IEC 62304:2015 Medical Device Software Lifecycle Processes?
105 GAMP 5 - Good Automated Manufacturing Practice controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice with 17 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 IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice (17 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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