Cross-Framework Mapping

FDA 21 CFR Part 11vsRussia Federal Law on Personal Data (152-FZ)

See exactly how FDA 21 CFR Part 11 controls map to Russia Federal Law on Personal Data (152-FZ). Pre-computed mappings, identified gaps, and coverage analysis.

4
Controls Mapped
9
Gaps Found
31%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to Russia Federal Law on Personal Data (152-FZ) with 31% coverage across 4 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 9 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 | 332K+ cross-framework mappings

Control Mappings

Showing 4 of 4 mapped controls across 3 domains. Sign up to explore all 332K+ 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)

Part11.30Controls for open systems (21 CFR §11.30)
RUSPD-4Special Categories, Biometric Data

21 CFR Part 11 Subpart C - Electronic Signatures (§11.200 + §11.300 Components, Controls, ID Codes and Passwords)(1 mappings)

Part11.300Controls for identification codes and passwords (21 CFR §11.300)
RUSPD-2Lawful Basis, Consent, Notice

21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(2 mappings)

Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
RUSPD-4Special Categories, Biometric Data
Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))
RUSPD-4Special Categories, Biometric Data

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What are the key differences between FDA 21 CFR Part 11 and Russia Federal Law on Personal Data (152-FZ)?

FDA 21 CFR Part 11 has 13 controls across its framework, while Russia Federal Law on Personal Data (152-FZ) covers 8 controls. Direct mapping analysis identifies 4 overlapping controls (31% coverage). The frameworks diverge most significantly in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)), where 2 FDA 21 CFR Part 11 controls have no direct Russia Federal Law on Personal Data (152-FZ) equivalent.

How many controls map between FDA 21 CFR Part 11 and Russia Federal Law on Personal Data (152-FZ)?

Of 13 total FDA 21 CFR Part 11 controls, 4 map directly to Russia Federal Law on Personal Data (152-FZ) controls — representing 31% coverage. The remaining 9 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 Russia Federal Law on Personal Data (152-FZ)?

9 FDA 21 CFR Part 11 controls have no direct equivalent in Russia Federal Law on Personal Data (152-FZ). The highest concentration of gaps is in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) 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 Russia Federal Law on Personal Data (152-FZ)?

The domain with the highest gap count is 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) (2 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.