Glossary

FDA 21 CFR Part 11

What is FDA 21 CFR Part 11?

FDA 21 CFR Part 11 is a U.S. Food and Drug Administration (FDA) regulation that mandates use of electronic records and signatures in regulated industries such as pharmaceuticals, biotechnology, medical devices, food and beverages, etc.

What industries comply with FDA 21 CFR Part 11?

Regulated industries such as pharmaceuticals, contract research organizations (CROs), medical devices, biotechnology, food and beverages, etc comply with FDA 21 CFR Part 11.

What are the key requirements of FDA 21 CFR Part 11?

The requirements of FDA 21 CFR Part 11 include use and validation of electronic signatures to ensure accuracy and reliability, establishment of controls for ensuring authenticity and integrity, implementation of audit trails to record and track changes in electronic records and compliance with controls for system access, data security and backup.

How does FDA 21 CFR Part 11 ensure data integrity in regulated industries?

FDA 21 CFR Part 11 ensures data integrity with electronic records. It maintains accuracy with proper controls to limit unauthorized access, deletions and changes. This fosters reliability.