FDA 21 CFR Part 11vsUS EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
See exactly how FDA 21 CFR Part 11 controls map to US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements with 15% coverage across 2 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 11 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 2 of 2 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
21 CFR Part 11 Subpart C - Electronic Signatures (§11.200 + §11.300 Components, Controls, ID Codes and Passwords)(1 mappings)
21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(1 mappings)
Related Comparisons
Other FDA 21 CFR Part 11 comparisons
Other US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements comparisons
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What are the key differences between FDA 21 CFR Part 11 and US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements?
FDA 21 CFR Part 11 has 13 controls across its framework, while US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements covers 3 controls. Direct mapping analysis identifies 2 overlapping controls (15% coverage). The frameworks diverge most significantly in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)), where 3 FDA 21 CFR Part 11 controls have no direct US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements equivalent.
How many controls map between FDA 21 CFR Part 11 and US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements?
Of 13 total FDA 21 CFR Part 11 controls, 2 map directly to US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements controls — representing 15% coverage. The remaining 11 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 US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements?
11 FDA 21 CFR Part 11 controls have no direct equivalent in US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements. The highest concentration of gaps is in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) with 3 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 US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements?
The domain with the highest gap count is 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) (3 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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