21 CFR Part 211 - Current Good Manufacturing Practice vs COBIT 2019
What is the difference between 21 CFR Part 211 - Current Good Manufacturing Practice and COBIT 2019?
21 CFR Part 211 - Current Good Manufacturing Practice is a compliance framework applying in the United States, with 76 controls across 20 domains. COBIT 2019 is a compliance framework applying in International, with 231 controls across 5 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 Practice76 controls
COBIT 2019231 controls
Questions people ask about 21 CFR Part 211 - Current Good Manufacturing Practice and COBIT 2019
What is the difference between 21 CFR Part 211 - Current Good Manufacturing Practice and COBIT 2019?
21 CFR Part 211 - Current Good Manufacturing Practice has 76 controls while COBIT 2019 has 231 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 COBIT 2019?
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 COBIT 2019 so you can identify shared requirements and avoid duplicate effort.
How do 21 CFR Part 211 - Current Good Manufacturing Practice and COBIT 2019 controls map to each other?
Our platform maps controls between 21 CFR Part 211 - Current Good Manufacturing Practice and COBIT 2019 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 COBIT 2019?
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 controlsCOBIT 2019 vs MTCS (Singapore)2 shared controlsCOBIT 2019 vs Protective Security Policy Framework (PSPF) Release 20242 shared controlsCOBIT 2019 vs PSD2 SCA2 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between 21 CFR Part 211 - Current Good Manufacturing Practice and COBIT 2019 on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.