21 CFR Part 11

What 21 CFR Part 11 Is

A U.S. FDA regulation under Title 21 of the Code of Federal Regulations, Part 11, that sets the conditions under which electronic records and electronic signatures are considered equivalent to paper records and handwritten signatures.

Core Recordkeeping Requirements

Systems must maintain a secure, computer-generated audit trail that records changes to data — who made them, when, and why — without allowing deletion or alteration of the original entry.

Access Control Requirements

The regulation requires user authentication, role-based access control, and safeguards against unauthorized system access.

Impact on Plant Automation Systems

For pharmaceutical production lines, the goal is to upgrade the client's existing SCADA, PLC, and HMI systems to meet these recordkeeping requirements — not to build a new automation system from scratch — so that production data already being recorded can serve as valid evidence during regulatory inspections.