FDA 21 CFR Part 11vsPrivacy Act 1988 (Australia)
See exactly how FDA 21 CFR Part 11 controls map to Privacy Act 1988 (Australia). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to Privacy Act 1988 (Australia) with 38% coverage across 5 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 8 compliance gaps — primarily concentrated in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 9 of 9 mapped controls across 2 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
21 CFR Part 11 Subpart B - Electronic Records (§11.30 Open Systems, §11.50 + §11.70 Signature Manifestations and Linking)(3 mappings)
21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(6 mappings)
Related Comparisons
Other FDA 21 CFR Part 11 comparisons
Other Privacy Act 1988 (Australia) comparisons
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What are the key differences between FDA 21 CFR Part 11 and Privacy Act 1988 (Australia)?
FDA 21 CFR Part 11 has 13 controls across its framework, while Privacy Act 1988 (Australia) covers 8 controls. Direct mapping analysis identifies 5 overlapping controls (38% 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 Privacy Act 1988 (Australia) equivalent.
How many controls map between FDA 21 CFR Part 11 and Privacy Act 1988 (Australia)?
Of 13 total FDA 21 CFR Part 11 controls, 5 map directly to Privacy Act 1988 (Australia) controls — representing 38% coverage. The remaining 8 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 Privacy Act 1988 (Australia)?
8 FDA 21 CFR Part 11 controls have no direct equivalent in Privacy Act 1988 (Australia). 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 Privacy Act 1988 (Australia)?
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.
Related Resources
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