FDA 21 CFR Part 11vsAPRA CPS 234
See exactly how FDA 21 CFR Part 11 controls map to APRA CPS 234. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to APRA CPS 234 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 | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 323K+ mappings across 700 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 APRA CPS 234 comparisons
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What are the key differences between FDA 21 CFR Part 11 and APRA CPS 234?
FDA 21 CFR Part 11 has 13 controls across its framework, while APRA CPS 234 covers 35 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 APRA CPS 234 equivalent.
How many controls map between FDA 21 CFR Part 11 and APRA CPS 234?
Of 13 total FDA 21 CFR Part 11 controls, 1 map directly to APRA CPS 234 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 APRA CPS 234?
12 FDA 21 CFR Part 11 controls have no direct equivalent in APRA CPS 234. 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 APRA CPS 234?
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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