Review of GXP Audit Trails: Principles and Practice

Review of GXP Audit Trails: Principles and Practice

Bob McDowall
R D McDowall Ltd.

Course: SC069

1/2 Day Course

Intermediate Level

Wednesday: 03/20/2019

Data Management, Quality/Regulatory/Compliance, Electronic Laboratory, Laboratory Information and Management

$350 ($475 after 2/25/19)

More Course Info

Be sure to check out Bob’s other Short Courses:

Course Description

Audit trail review is mandated by GMP regulations and regulatory guidance documents for data integrity. What are the principles for this review based on the regulations and guidance? Should all audit trail entries be reviewed or can we review by exception? This course provides an interpretation of the regulations and guidance and then looks at practical ways to implement the principles.

Technical controls for applications and audit trails themselves for use by review by exception are discussed and there are interactive and workshop elements to the short course.

Target Audience

• Analytical staff in GMP regulated laboratories responsible for conducting second person and audit trail reviews
• Owners of computerised systems in regulated GMP laboratories
• GMP Laboratory managers responsible for computerised systems
• QA personnel responsible for computerised systems

Course Outline

• Introduction
• Regulatory Requirements for Review of Audit Trails
• Data Integrity Guidance for Audit Trail Review
• What are GMP relevant changes and deletions for audit trail review?
• Configuring and Validating Audit Trail Functionality
• Facilitated Discussion: Risk Based Review of Audit Trails
• Workshop: Review of Audit Trail Entries
• Technical Controls to Aid Audit Trail Review

Instructor Biography

An analytical chemist with over 45 years experience including 15 years working in the pharmaceutical industry and over 25 years working for the industry as a consultant. He is Director of R D McDowall Ltd. Bob is an ISO 17025 assessor and he has been involved with the validation of computerised systems for over 30 years and is the author of books on the validation of chromatography data systems and data integrity and data governance in regulated laboratories. Bob is also the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several Journals. He is also involved in the GAMP Data Integrity Special Interest Group and is a contributor and reviewer of the 2017 GAMP Guide for Records and Data Integrity