Remove Drugs Remove Gene Remove Laboratory Information Management System Remove Regulation
article thumbnail

Mastering 21 CFR Part 11 Compliance: A Comprehensive Guide for Clinical Trials in the Digital Age

Cloudbyz

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. Food and Drug Administration (FDA). Its central focus is electronic records and signatures. Let’s explore. What is 21 CFR Part 11?