21 CFR Part 11 Compliant: This term refers to a set of regulations set forth in the US Code of Federal Regulations (CFR) that provide guidance for electronic records and signatures used in the pharmaceutical and medical device industries. It requires organizations to use specific controls for the creation, storage, retention, and archiving of electronic documents as well as the implementation of user authentication measures for such documents. Following these regulations ensures that organizations can meet legal requirements for data integrity and compliance.