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Cross-Framework Mapping

FDA 21 CFR Part 11vsPCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)

See exactly how FDA 21 CFR Part 11 controls map to PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR). Pre-computed mappings, identified gaps, and coverage analysis.

2
Controls Mapped
11
Gaps Found
8%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR) 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 | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 2 of 2 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

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

Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)2 targets
→ASTWO-1Audit Planning, Scaling, Risk Assessment, and Integration
→ASTWO-3Entity-Level Controls and Period-End Financial Reporting Process

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Other PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR) comparisons

ISO/IEC 29147:2018 vs PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)4 mappingsISO/IEC 29134:2023 vs PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)4 mappingsISO/IEC 27014:2020 vs PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)4 mappingsNIST AI Risk Management Framework (AI RMF 1.0) vs PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)4 mappingsISO/IEC 27557:2022 - Organisational Privacy Risk Management vs PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)4 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)4 mappingsASIS SPC.1-2009 - Organizational Resilience Standard vs PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)4 mappingsISO/IEC 27031:2011 vs PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)4 mappings

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What are the key differences between FDA 21 CFR Part 11 and PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)?

FDA 21 CFR Part 11 has 13 controls across its framework, while PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR) covers 8 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 PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR) equivalent.

How many controls map between FDA 21 CFR Part 11 and PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)?

Of 13 total FDA 21 CFR Part 11 controls, 1 map directly to PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR) 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 PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)?

12 FDA 21 CFR Part 11 controls have no direct equivalent in PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR). 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 PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)?

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.