Remove Clinical Research Remove Drugs Remove Gene Therapy Remove Laboratory Information Management System
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). Laboratory Information Management Systems (LIMS): These systems manage the collection, processing, storage, and retrieval of laboratory data.