The Importance of Audit Trails in 21 CFR Part 11 Compliance
In regulated industries such as pharmaceuticals, biotechnology, and clinical research, maintaining the integrity of electronic records is essential. One of the core requirements of 21 CFR Part 11, which governs the use of electronic records and electronic signatures in FDA-regulated industries, is the implementation of audit trails. These audit trails are designed to ensure that every action performed on an electronic record can be traced, reviewed, and verified. This article will explore the significance of audit trails in 21 CFR Part 11 compliance, their key components, and best practices for organizations to manage them effectively.
What are Audit Trails?
An audit trail is a secure, time-stamped record that logs the details of all user activities performed on an electronic system or data. It provides a chronological history of changes made to electronic records, including who made the change, when it was made, and what specific action was performed. Audit trails are a critical part of 21 CFR Part 11 as they ensure that electronic records can be verified, protected from unauthorized changes, and are accessible for review during regulatory inspections.