Glossary
FDA 21 CFR Part 11
Quality Management Glossary Term
Category
Regulatory Compliance
Industry
Manufacturing, Medical Device, Aerospace, Life Sciences
Required By
ISO 9001 · ISO 13485 · FDA 21 CFR Part 11
Related Terms
CAPA · Audit Management · Risk Assessment
FDA 21 CFR Part 11 is an important quality management concept used in regulated industries to improve compliance, traceability, and operational quality.
What is FDA 21 CFR Part 11?
FDA 21 CFR Part 11 is a key process or concept used within quality management systems to support compliance and operational excellence.Why is FDA 21 CFR Part 11 important?
FDA 21 CFR Part 11 helps organizations improve traceability, maintain compliance, reduce risk, and support continuous improvement initiatives.Frequently Asked Questions
What does FDA 21 CFR Part 11 mean in quality management?
FDA 21 CFR Part 11 refers to a quality management concept commonly used in regulated manufacturing industries.
How is FDA 21 CFR Part 11 used?
FDA 21 CFR Part 11 is typically used within a quality management system to improve process control and regulatory compliance.
Related quality management terms
Last reviewed: May 19, 2026