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Cross-Framework Mapping

India DPDP ActvsFDA 21 CFR Part 11

See exactly how India DPDP Act controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

6
Controls Mapped
2
Gaps Found
38%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

India DPDP Act maps to FDA 21 CFR Part 11 with 38% coverage across 3 directly mapped controls. Analysis of 8 India DPDP Act controls identifies 5 compliance gaps — primarily concentrated in DPDP DPBI + Enforcement + Penalties (Sec 18-42).

Source: TheArtOfService Knowledge Graph | 8 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 6 of 6 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

DPDP Cross-Border + Breach (Sec 16-17)(1 mappings)

DPDP-CrossBorder-Transfer-Breach-Notification-Sec16-Sec17-DPBI-72Hour-IT-Act-CoordDPDP Act Sections 16-17 + Cross-Border Personal Data Transfer + Negative List Approach + Personal Data Breach Notification to DPBI 72 Hours + Cooperation with Adjudication + Coord with CERT-In + IT Act 43A Repeal
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))

DPDP Data Principal Rights (Sec 11-14)(1 mappings)

DPDP-DataPrincipalRights-Sec11to14-Access-Correction-Erasure-Grievance-Nominate-WithdrawDPDP Act Sections 11-14 + Data Principal Rights + Access + Correction + Erasure + Grievance Redressal + Right to Nominate + Withdraw Consent + Duties + Verification of Identity
→Part11.30Controls for open systems (21 CFR §11.30)

DPDP SDF + DPO + Audit + DPIA (Sec 10-11)(4 mappings)

DPDP-SignificantDataFiduciary-SDF-Sec10-DPO-IndependentAuditor-DPIA-AlgorithmicDPDP Act Sections 10-11 + Significant Data Fiduciary (SDF) + Data Protection Officer + Independent Data Auditor + DPIA + Algorithmic Software Audit + Privacy by Design + Records of Processing Activities4 targets
→Part11.30Controls for open systems (21 CFR §11.30)
→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
→Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)
→Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))

Related Comparisons

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Other FDA 21 CFR Part 11 comparisons

Annex 11 to EU GMP - Computerised Systems vs FDA 21 CFR Part 119 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs FDA 21 CFR Part 117 mappingsAzure Security Benchmark vs FDA 21 CFR Part 116 mappingsAWS Well-Architected Security Pillar vs FDA 21 CFR Part 116 mappingsASD Strategies to Mitigate Cyber Security Incidents vs FDA 21 CFR Part 116 mappingsCISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs FDA 21 CFR Part 116 mappingsVermont Artificial Intelligence and Consumer Data Act (AICDA) vs FDA 21 CFR Part 115 mappingsPrivacy Act 1988 (Australia) vs FDA 21 CFR Part 115 mappings

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What are the key differences between India DPDP Act and FDA 21 CFR Part 11?

India DPDP Act has 8 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 3 overlapping controls (38% coverage). The frameworks diverge most significantly in DPDP DPBI + Enforcement + Penalties (Sec 18-42), where 1 India DPDP Act controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between India DPDP Act and FDA 21 CFR Part 11?

Of 8 total India DPDP Act controls, 3 map directly to FDA 21 CFR Part 11 controls — representing 38% coverage. The remaining 5 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping India DPDP Act to FDA 21 CFR Part 11?

5 India DPDP Act controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in DPDP DPBI + Enforcement + Penalties (Sec 18-42) with 1 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 India DPDP Act and FDA 21 CFR Part 11?

The domain with the highest gap count is DPDP DPBI + Enforcement + Penalties (Sec 18-42) (1 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.