TheArtOfService
Cross-Framework Mapping

APPIvsFDA 21 CFR Part 11

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

18
Controls Mapped
3
Gaps Found
19%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

APPI maps to FDA 21 CFR Part 11 with 19% coverage across 8 directly mapped controls. Analysis of 21 APPI controls identifies 34 compliance gaps — primarily concentrated in APPI: Data Subject Rights.

Source: TheArtOfService Knowledge Graph | 21 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 18 of 18 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Individual Rights(1 mappings)

APPI-13Correction, Addition, and Deletion
→Part11.30Controls for open systems (21 CFR §11.30)

APPI: Data Security(2 mappings)

APPI-13Correction, Addition, and Deletion
→Part11.30Controls for open systems (21 CFR §11.30)
APPI-15Leakage Notification
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))

Incident(1 mappings)

APPI-15Leakage Notification
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))

Regulator(3 mappings)

APPI-19PPC Cooperation and Investigation3 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.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))

APPI: Data Governance(7 mappings)

APPI-19PPC Cooperation and Investigation3 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.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))
APPI-21Governance and DPO Equivalent4 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))

Governance(4 mappings)

APPI-21Governance and DPO Equivalent4 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))

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What are the key differences between APPI and FDA 21 CFR Part 11?

APPI has 21 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 8 overlapping controls (19% coverage). The frameworks diverge most significantly in APPI: Data Subject Rights, where 7 APPI controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between APPI and FDA 21 CFR Part 11?

Of 21 total APPI controls, 8 map directly to FDA 21 CFR Part 11 controls — representing 19% coverage. The remaining 34 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping APPI to FDA 21 CFR Part 11?

34 APPI controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in APPI: Data Subject Rights with 7 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 APPI and FDA 21 CFR Part 11?

The domain with the highest gap count is APPI: Data Subject Rights (7 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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