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Cross-Framework Mapping

21 CFR Part 211 — Current Good Manufacturing PracticevsNIST SP 800-171A Rev 3 — Assessing CUI Security Requirements

See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements. Pre-computed mappings, identified gaps, and coverage analysis.

15
Controls Mapped
42
Gaps Found
9%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

21 CFR Part 211 — Current Good Manufacturing Practice maps to NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements with 9% coverage across 5 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 52 compliance gaps — primarily concentrated in Subpart J — Records and Reports.

Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 15 of 15 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Subpart A — General Provisions(3 mappings)

CFR211-A-3Section 211.3 — Definitions3 targets
→3.3Record Completion and Maintenance
→FEDRAMP-CM-6Configuration Settings
→FEDRAMP-CP-9System Backup

Subpart C — Buildings and Facilities(3 mappings)

CFR211-C-48Section 211.48 — Plumbing3 targets
→3.1Food Safety and Quality Manual
→3.2Document Control
→3.4Internal Audits

Subpart F — Production and Process Controls(3 mappings)

CFR211-F-113Section 211.113 — Control of Microbiological Contamination3 targets
→3.1Food Safety and Quality Manual
→3.2Document Control
→3.4Internal Audits

Subpart I — Laboratory Controls(3 mappings)

CFR211-I-176Section 211.176 — Penicillin Contamination3 targets
→3.1Food Safety and Quality Manual
→3.2Document Control
→3.4Internal Audits

Subpart J — Records and Reports(3 mappings)

CFR211-J-184Section 211.184 — Component, Drug Product Container, Closure, and Labeling Records3 targets
→3.16System and Services Acquisition
→3.17Supply Chain Risk Management
→3.5Management of Suppliers

Related Comparisons

Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons

21 CFR Part 211 — Current Good Manufacturing Practice vs FDA Quality Management System Regulation (QMSR)8 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs US OFAC Sanctions Compliance Framework7 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs CFTC System Safeguards (17 CFR 37, 38, 39, 49)5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs GLI-33 — Gaming Laboratories International Event Wagering Systems5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs EIOPA Guidelines on ICT Security and Governance (2023)5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs TISAX — Trusted Information Security Assessment Exchange5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs Telecommunications Sector Security Reforms (TSSR)5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs Defence Security Principles Framework (DSPF)5 mappings

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

UK Telecommunications (Security) Act 2021 vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsSouth Korea Cloud Security Assurance Program (CSAP) vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsPAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsCanada ITSG-33 — IT Security Risk Management vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsNew Zealand Information Security Manual (NZISM) vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsMARS-E — Minimum Acceptable Risk Standards for Exchanges vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsNRC 10 CFR 73.54 — Nuclear Facility Cybersecurity vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsTISAX — Trusted Information Security Assessment Exchange vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements20 mappings

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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements?

21 CFR Part 211 — Current Good Manufacturing Practice has 57 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 (9% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 8 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements equivalent.

How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements?

Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 5 map directly to NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements controls — representing 9% coverage. The remaining 52 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping 21 CFR Part 211 — Current Good Manufacturing Practice to NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements?

52 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements. The highest concentration of gaps is in Subpart J — Records and Reports with 8 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 21 CFR Part 211 — Current Good Manufacturing Practice and NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements?

The domain with the highest gap count is Subpart J — Records and Reports (8 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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