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Cross-Framework Mapping

FDA 21 CFR Part 11vsCanada ITSG-33 - IT Security Risk Management

See exactly how FDA 21 CFR Part 11 controls map to Canada ITSG-33 - IT Security Risk Management. Pre-computed mappings, identified gaps, and coverage analysis.

1
Controls Mapped
12
Gaps Found
8%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to Canada ITSG-33 - IT Security Risk Management 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 | 706 frameworks | 324K+ cross-framework mappings

Control Mappings

Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 324K+ mappings across 706 frameworks.

21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(1 mappings)

Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
→CA-ITSG33-SC-01Security Control Catalogue

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Other Canada ITSG-33 - IT Security Risk Management comparisons

NIST SP 800-53 Rev 5 vs Canada ITSG-33 - IT Security Risk Management23 mappingsNIST Cybersecurity Framework 2.0 vs Canada ITSG-33 - IT Security Risk Management18 mappingsAzure Security Benchmark vs Canada ITSG-33 - IT Security Risk Management2 mappingsPAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments vs Canada ITSG-33 - IT Security Risk Management2 mappingsOWASP DevSecOps Maturity Model (DSOMM) vs Canada ITSG-33 - IT Security Risk Management2 mappingsNIST SP 800-146 vs Canada ITSG-33 - IT Security Risk Management2 mappingsNIST SP 800-145 vs Canada ITSG-33 - IT Security Risk Management2 mappingsNIST SP 800-144 vs Canada ITSG-33 - IT Security Risk Management2 mappings

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What are the key differences between FDA 21 CFR Part 11 and Canada ITSG-33 - IT Security Risk Management?

FDA 21 CFR Part 11 has 13 controls across its framework, while Canada ITSG-33 - IT Security Risk Management covers 26 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 3 FDA 21 CFR Part 11 controls have no direct Canada ITSG-33 - IT Security Risk Management equivalent.

How many controls map between FDA 21 CFR Part 11 and Canada ITSG-33 - IT Security Risk Management?

Of 13 total FDA 21 CFR Part 11 controls, 1 map directly to Canada ITSG-33 - IT Security Risk Management 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 Canada ITSG-33 - IT Security Risk Management?

12 FDA 21 CFR Part 11 controls have no direct equivalent in Canada ITSG-33 - IT Security Risk Management. 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 Canada ITSG-33 - IT Security Risk Management?

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.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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.