TheArtOfService
Cross-Framework Mapping

FDA 21 CFR Part 11vsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements

See exactly how FDA 21 CFR Part 11 controls map to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements. 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements 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 | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 8 of 8 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

21 CFR Part 11 Subpart B - Electronic Records (§11.10 Closed Systems)(2 mappings)

Part11.10Controls for closed systems (21 CFR §11.10)2 targets
→3.2.1Account data storage minimised
→3.9Encrypt Data on Removable Media

21 CFR Part 11 Subpart C - Electronic Signatures (§11.200 + §11.300 Components, Controls, ID Codes and Passwords)(2 mappings)

Part11.300Controls for identification codes and passwords (21 CFR §11.300)2 targets
→3.7Establish and Maintain a Data Classification Scheme
→3.7.1Key generation procedures

21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(4 mappings)

Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))2 targets
→3.10Encrypt Sensitive Data in Transit
→3.7.1Key generation procedures
Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
→3.3.1Audit Record Creation
Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)
→3.11Encrypt Sensitive Data at Rest

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 Vermont Artificial Intelligence and Consumer Data Act (AICDA)5 mappingsFDA 21 CFR Part 11 vs Privacy Act 1988 (Australia)5 mappings

Other NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements comparisons

NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements20 mappingsNIST SP 800-53 Rev 5 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements18 mappingsMTCS (Singapore) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements17 mappingsNIST Privacy Framework vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements16 mappingsNIST SP 800-146 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappingsNIST SP 800-145 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappingsNIST SP 800-144 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappingsISMAP (Japan) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappings

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 723 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • ✓ 723 framework browser
  • ✓ Cross-framework mappings (332K+)
  • ✓ 824 compliance assessments
  • ✓ 3 AI queries & searches per day
Get Started Free
Recommended
$49/month

Professional

  • ✓ Unlimited AI Compliance Advisory
  • ✓ Unlimited full-text search
  • ✓ Framework self-assessment
  • ✓ PDF, Excel & CSV exports
Start 7-Day Free Trial →

Popular framework comparisons

NIST CSF vs NIST 800-53ISO 27001 vs NIST CSFCMMC vs NIST 800-53FedRAMP vs NIST 800-53NIST CSF vs SOC 2HIPAA vs NIST 800-53ISO 27001 vs SOC 2ISO 27001 vs ISO 27701

What are the key differences between FDA 21 CFR Part 11 and NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

FDA 21 CFR Part 11 has 13 controls across its framework, while NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements covers 35 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements equivalent.

How many controls map between FDA 21 CFR Part 11 and NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

Of 13 total FDA 21 CFR Part 11 controls, 5 map directly to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

8 FDA 21 CFR Part 11 controls have no direct equivalent in NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements. 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

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

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.