21 CFR Part 211 - Current Good Manufacturing Practice vs NIST SP 800-53 Rev 5
What is the difference between 21 CFR Part 211 - Current Good Manufacturing Practice and NIST SP 800-53 Rev 5?
21 CFR Part 211 - Current Good Manufacturing Practice is a other framework applying in the United States, with 78 controls across 21 domains. NIST SP 800-53 Rev 5 is a information security framework applying in the United States, with 192 controls across 24 domains. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.
21 CFR Part 211 - Current Good Manufacturing Practice78 controls
NIST SP 800-53 Rev 5192 controls
Questions people ask about 21 CFR Part 211 - Current Good Manufacturing Practice and NIST SP 800-53 Rev 5
What is the difference between 21 CFR Part 211 - Current Good Manufacturing Practice and NIST SP 800-53 Rev 5?
21 CFR Part 211 - Current Good Manufacturing Practice has 78 controls while NIST SP 800-53 Rev 5 has 192 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.
Do I need both 21 CFR Part 211 - Current Good Manufacturing Practice and NIST SP 800-53 Rev 5?
Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between 21 CFR Part 211 - Current Good Manufacturing Practice and NIST SP 800-53 Rev 5 so you can identify shared requirements and avoid duplicate effort.
How do 21 CFR Part 211 - Current Good Manufacturing Practice and NIST SP 800-53 Rev 5 controls map to each other?
Our platform maps controls between 21 CFR Part 211 - Current Good Manufacturing Practice and NIST SP 800-53 Rev 5 at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.
Which framework should I implement first, 21 CFR Part 211 - Current Good Manufacturing Practice or NIST SP 800-53 Rev 5?
The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.
Each framework on its own
Comparisons people read next
Each of these compares one of the two standards above against another it shares controls with.
21 CFR Part 211 - Current Good Manufacturing Practice vs 21 CFR Part 58 - Good Laboratory Practice (GLP)12 shared controls21 CFR Part 211 - Current Good Manufacturing Practice vs FDA Quality Management System Regulation (QMSR)7 shared controls21 CFR Part 211 - Current Good Manufacturing Practice vs Protective Security Policy Framework (PSPF) Release 20244 shared controlsNIST SP 800-53 Rev 5 vs ISO 27002:2022118 shared controlsNIST SP 800-53 Rev 5 vs ISO 27001:2022118 shared controlsNIST SP 800-53 Rev 5 vs PCI DSS 4.0111 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between 21 CFR Part 211 - Current Good Manufacturing Practice and NIST SP 800-53 Rev 5 on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.