21 CFR Part 211 - Current Good Manufacturing PracticevsGAMP 5 - Good Automated Manufacturing Practice
See exactly how 21 CFR Part 211 - Current Good Manufacturing Practice controls map to GAMP 5 - Good Automated Manufacturing Practice. 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 GAMP 5 - Good Automated Manufacturing Practice with 3% coverage across 2 directly mapped controls. Analysis of 78 21 CFR Part 211 - Current Good Manufacturing Practice controls identifies 76 compliance gaps — primarily concentrated in Subpart F - Production and Process Controls.
Source: TheArtOfService Knowledge Graph | 78 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Subpart A - General Provisions(2 mappings)
Subpart J - Records and Reports(1 mappings)
Related Comparisons
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Other GAMP 5 - Good Automated Manufacturing Practice comparisons
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What are the key differences between 21 CFR Part 211 - Current Good Manufacturing Practice and GAMP 5 - Good Automated Manufacturing Practice?
21 CFR Part 211 - Current Good Manufacturing Practice has 78 controls across its framework, while GAMP 5 - Good Automated Manufacturing Practice covers 11 controls. Direct mapping analysis identifies 2 overlapping controls (3% coverage). The frameworks diverge most significantly in Subpart F - Production and Process Controls, where 8 21 CFR Part 211 - Current Good Manufacturing Practice controls have no direct GAMP 5 - Good Automated Manufacturing Practice equivalent.
How many controls map between 21 CFR Part 211 - Current Good Manufacturing Practice and GAMP 5 - Good Automated Manufacturing Practice?
Of 78 total 21 CFR Part 211 - Current Good Manufacturing Practice controls, 2 map directly to GAMP 5 - Good Automated Manufacturing Practice controls — representing 3% coverage. The remaining 76 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 GAMP 5 - Good Automated Manufacturing Practice?
76 21 CFR Part 211 - Current Good Manufacturing Practice controls have no direct equivalent in GAMP 5 - Good Automated Manufacturing Practice. The highest concentration of gaps is in Subpart F - Production and Process Controls with 8 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 GAMP 5 - Good Automated Manufacturing Practice?
The domain with the highest gap count is Subpart F - Production and Process Controls (8 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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