TheArtOfService
Cross-Framework Mapping

FDA 21 CFR Part 11vsVermont Artificial Intelligence and Consumer Data Act (AICDA)

See exactly how FDA 21 CFR Part 11 controls map to Vermont Artificial Intelligence and Consumer Data Act (AICDA). Pre-computed mappings, identified gaps, and coverage analysis.

8
Controls Mapped
5
Gaps Found
38%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to Vermont Artificial Intelligence and Consumer Data Act (AICDA) 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 | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 8 of 8 mapped controls across 3 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

21 CFR Part 11 Subpart B - Electronic Records (§11.30 Open Systems, §11.50 + §11.70 Signature Manifestations and Linking)(2 mappings)

Part11.30Controls for open systems (21 CFR §11.30)2 targets
→VERMONTAICDA-3Bias Testing, Discrimination Prevention, Transparency
→VERMONTAICDA-4Vermont AG Enforcement and Cure

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)
→VERMONTAICDA-3Bias Testing, Discrimination Prevention, Transparency

21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(5 mappings)

Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))2 targets
→VERMONTAICDA-3Bias Testing, Discrimination Prevention, Transparency
→VERMONTAICDA-4Vermont AG Enforcement and Cure
Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)
→VERMONTAICDA-4Vermont AG Enforcement and Cure
Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))2 targets
→VERMONTAICDA-3Bias Testing, Discrimination Prevention, Transparency
→VERMONTAICDA-4Vermont AG Enforcement and Cure

Related Comparisons

Other FDA 21 CFR Part 11 comparisons

FDA 21 CFR Part 11 vs Annex 11 to EU GMP - Computerised Systems9 mappingsFDA 21 CFR Part 11 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)7 mappingsFDA 21 CFR Part 11 vs Azure Security Benchmark6 mappingsFDA 21 CFR Part 11 vs AWS Well-Architected Security Pillar6 mappingsFDA 21 CFR Part 11 vs ASD Strategies to Mitigate Cyber Security Incidents6 mappingsFDA 21 CFR Part 11 vs CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.06 mappingsFDA 21 CFR Part 11 vs Privacy Act 1988 (Australia)5 mappingsFDA 21 CFR Part 11 vs Ley Orgánica de Protección de Datos Personales (LOPDP)5 mappings

Other Vermont Artificial Intelligence and Consumer Data Act (AICDA) comparisons

Peru DPL vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)3 mappingsFederal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL) vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)3 mappingsIndiana Consumer Data Protection Act vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)3 mappingsIowa Consumer Data Protection Act vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)3 mappingsKentucky Consumer Data Protection Act vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)3 mappingsNIST Privacy Framework vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)3 mappingsNRF Cybersecurity and Data Privacy Framework (National Retail Federation) vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)3 mappingsFamily Educational Rights and Privacy Act (FERPA) vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)3 mappings

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What are the key differences between FDA 21 CFR Part 11 and Vermont Artificial Intelligence and Consumer Data Act (AICDA)?

FDA 21 CFR Part 11 has 13 controls across its framework, while Vermont Artificial Intelligence and Consumer Data Act (AICDA) covers 4 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 Vermont Artificial Intelligence and Consumer Data Act (AICDA) equivalent.

How many controls map between FDA 21 CFR Part 11 and Vermont Artificial Intelligence and Consumer Data Act (AICDA)?

Of 13 total FDA 21 CFR Part 11 controls, 5 map directly to Vermont Artificial Intelligence and Consumer Data Act (AICDA) 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 Vermont Artificial Intelligence and Consumer Data Act (AICDA)?

8 FDA 21 CFR Part 11 controls have no direct equivalent in Vermont Artificial Intelligence and Consumer Data Act (AICDA). 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 Vermont Artificial Intelligence and Consumer Data Act (AICDA)?

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

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

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