Audit trails are considered the key to the security of a system since they track changes to data and metadata. In this way, an incomplete or absent audit trail can impact data integrity or even product quality. The absence of an audit trail is considered to be "highly significant when there are data discrepancies" according to the FDA.
The use of computer generated, time-stamped audit trails are a significant part of the Controls for Closed Systems. (§11.10(e)) for 21 CFR Part 11 1 as well as regulations and guidances from across the globe, covering GMP, GLP, and GCP data.
This white paper explains Empower Software audit trails and logs: How to locate them in our chromatography data software, and why they are important to reviewers.
Want to learn more about Audit Trails? Watch our on-demand webinar A Risk-Based Approach to Reviewing Electronic Chromatographic Data and Audit Trails with Data Integrity in Mind