FedRAMP Rev 5vs21 CFR Part 211 - Current Good Manufacturing Practice
See exactly how FedRAMP Rev 5 controls map to 21 CFR Part 211 - Current Good Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FedRAMP Rev 5 maps to 21 CFR Part 211 - Current Good Manufacturing Practice with 25% coverage across 3 directly mapped controls. Analysis of 12 FedRAMP Rev 5 controls identifies 9 compliance gaps — primarily concentrated in FedRAMP: OMB M-24-15 Modernization, FedRAMP 2.0 and Coordination with StateRAMP / GovRAMP.
Source: TheArtOfService Knowledge Graph | 12 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.
FedRAMP: Authorization Boundary, SSP, SAR, POA&M and System Documentation(2 mappings)
FedRAMP: Continuous Monitoring (ConMon) and Significant Change Requests(1 mappings)
Related Comparisons
Other FedRAMP Rev 5 comparisons
Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons
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What are the key differences between FedRAMP Rev 5 and 21 CFR Part 211 - Current Good Manufacturing Practice?
FedRAMP Rev 5 has 12 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 78 controls. Direct mapping analysis identifies 3 overlapping controls (25% coverage). The frameworks diverge most significantly in FedRAMP: OMB M-24-15 Modernization, FedRAMP 2.0 and Coordination with StateRAMP / GovRAMP, where 2 FedRAMP Rev 5 controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.
How many controls map between FedRAMP Rev 5 and 21 CFR Part 211 - Current Good Manufacturing Practice?
Of 12 total FedRAMP Rev 5 controls, 3 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls — representing 25% coverage. The remaining 9 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FedRAMP Rev 5 to 21 CFR Part 211 - Current Good Manufacturing Practice?
9 FedRAMP Rev 5 controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. The highest concentration of gaps is in FedRAMP: OMB M-24-15 Modernization, FedRAMP 2.0 and Coordination with StateRAMP / GovRAMP with 2 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 FedRAMP Rev 5 and 21 CFR Part 211 - Current Good Manufacturing Practice?
The domain with the highest gap count is FedRAMP: OMB M-24-15 Modernization, FedRAMP 2.0 and Coordination with StateRAMP / GovRAMP (2 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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