Audit Trail Review

Objectives

• You will learn the current regulatory requirements and regulatory expectations for an audit trail (review)
• All GMP-relevant data (changes and deletions) should be audit trailed – you will learn how to identify GMP-relevant data
• Event and audit logs: you will understand the differences between and what the regulators expect
• How should an audit trail review be performed? You will get familiar with the content and the frequency of an audit trail review

Background

Audit Trail Reviews are required by international regulations like US 21 CFR Part 11 and EU GMP Guide Annex 11: Clause 9 requests:

“Consideration should be given, based on a risk assessment, to building into the system the creation of a record of all GMP-relevant changes and deletions (a system generated “audit trail”). For change or deletion of GMP-relevant data the reason should be documented. Audit trails need to be available and convertible to a generally intelligible form and regularly reviewed”

Regulators focus on the (creation), modification and deletion of (GMP-relevant) data while many IT systems are not able to generate audit trails at all or they are not able to generate audit trails for GMP-relevant data.

Therefore, this course is designed to support you to identify GMP-relevant data and how to perform and document an Audit Trail review as part of a second person review.