The 21 CFR Part 11 Regulation

Developments in documentation technology, specifically electronic records and electronic signatures, offered companies advantages over paper-based documentation. Companies in regulated industries sought to use these electronic record and electronic signature capabilities to satisfy regulatory requirements.

The United States government responded by updating the Code of Federal Regulations (CFR) with guidance in the form of regulation 21 CFR Part 11, governing the use of electronic records and electronic signatures needed or used to satisfy FDA requirements.