FDA 21 CFR Part 11vsNIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
See exactly how FDA 21 CFR Part 11 controls map to NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems with 8% coverage across 1 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 12 compliance gaps — primarily concentrated in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
21 CFR Part 11 Subpart B - Electronic Records (§11.30 Open Systems, §11.50 + §11.70 Signature Manifestations and Linking)(1 mappings)
Related Comparisons
Other FDA 21 CFR Part 11 comparisons
Other NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems comparisons
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What are the key differences between FDA 21 CFR Part 11 and NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems?
FDA 21 CFR Part 11 has 13 controls across its framework, while NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems covers 8 controls. Direct mapping analysis identifies 1 overlapping controls (8% coverage). The frameworks diverge most significantly in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)), where 4 FDA 21 CFR Part 11 controls have no direct NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems equivalent.
How many controls map between FDA 21 CFR Part 11 and NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems?
Of 13 total FDA 21 CFR Part 11 controls, 1 map directly to NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems controls — representing 8% coverage. The remaining 12 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FDA 21 CFR Part 11 to NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems?
12 FDA 21 CFR Part 11 controls have no direct equivalent in NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems. The highest concentration of gaps is in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) with 4 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 FDA 21 CFR Part 11 and NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems?
The domain with the highest gap count is 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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