FDA 21 CFR Part 11vsCISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
See exactly how FDA 21 CFR Part 11 controls map to CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 with 46% coverage across 6 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 7 compliance gaps — primarily concentrated in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 15 of 15 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
21 CFR Part 11 Subpart B - Electronic Records (§11.10 Closed Systems)(3 mappings)
21 CFR Part 11 Subpart B - Electronic Records (§11.30 Open Systems, §11.50 + §11.70 Signature Manifestations and Linking)(4 mappings)
21 CFR Part 11 Subpart C - Electronic Signatures (§11.200 + §11.300 Components, Controls, ID Codes and Passwords)(4 mappings)
21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(4 mappings)
Related Comparisons
Other FDA 21 CFR Part 11 comparisons
Other CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 comparisons
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What are the key differences between FDA 21 CFR Part 11 and CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0?
FDA 21 CFR Part 11 has 13 controls across its framework, while CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 covers 35 controls. Direct mapping analysis identifies 6 overlapping controls (46% coverage). The frameworks diverge most significantly in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions), where 2 FDA 21 CFR Part 11 controls have no direct CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 equivalent.
How many controls map between FDA 21 CFR Part 11 and CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0?
Of 13 total FDA 21 CFR Part 11 controls, 6 map directly to CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 controls — representing 46% coverage. The remaining 7 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 CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0?
7 FDA 21 CFR Part 11 controls have no direct equivalent in CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0. The highest concentration of gaps is in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions) 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 FDA 21 CFR Part 11 and CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0?
The domain with the highest gap count is 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions) (2 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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