21 CFR Part 11 Glossary Definition

Term 21 CFR Part 11
Definition

21 CFR Part 11 is a current regulation associated with U.S. Food and Drug Administration for Cybersecurity, Compliance, and Access work. It supports Cybersecurity, Compliance, and Access work by defining or governing controlled records, evidence, regulated documentation, or compliance obligations.

Context & Usage

U.S. regulation for electronic records and electronic signatures; not merely a general documentation-control rule. Professionals may encounter it in documentation programs, governance reviews, training initiatives, compliance work, standards research, or change efforts depending on the setting.

Categories Technical Writing and Documentation, Knowledge Management and Content Governance, Cybersecurity, Compliance, and Access Management, Enterprise Applications, CRM, and Contact Center Systems