21 CFR Part 211 — Current Good Manufacturing PracticevsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
21 CFR Part 211 — Current Good Manufacturing Practice maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 7% coverage across 4 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 53 compliance gaps — primarily concentrated in Subpart J — Records and Reports.
Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart A — General Provisions(3 mappings)
Subpart C — Buildings and Facilities(1 mappings)
Subpart F — Production and Process Controls(1 mappings)
Subpart I — Laboratory Controls(1 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and IEC 62304:2015 Medical Device Software Lifecycle Processes?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 4 overlapping controls (7% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 9 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 4 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 7% coverage. The remaining 53 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping 21 CFR Part 211 — Current Good Manufacturing Practice to IEC 62304:2015 Medical Device Software Lifecycle Processes?
53 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Subpart J — Records and Reports with 9 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 21 CFR Part 211 — Current Good Manufacturing Practice and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Subpart J — Records and Reports (9 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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