Audit Trail Review by Exception: Reducing Reviewer Burden Without Weakening Detection

In FDA and globally regulated environments, audit trail review has become one of the most resource-intensive and misunderstood compliance activities. Many organizations continue to apply manual, exhaustive review approaches that generate reviewer fatigue, slow batch release, and dilute focus on truly critical events. This session explores how to implement a risk-based, "review by exception" strategy that reduces reviewer burden while strengthening the ability to detect meaningful compliance, data integrity, cybersecurity, and operational risks. Attendees will learn how modern approaches aligned with FDA expectations, data integrity guidance, and risk-based validation principles can improve efficiency without sacrificing control. The discussion will also address the role of AI-enabled analytics, automation, prioritizing risk, and ensuring human critical thinking remains the final guardrail for decision-making. WHY YOU SHOULD ATTEND This webinar is intended for those involved in planning, execution, and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products. Functions that are applicable include research and development, manufacturing, Quality Control testing, distribution, clinical trial management, sample labeling, adverse events management, and post-marketing surveillance. Whether involved in software development, testing, implementation, validation, maintenance or use of AI-enabled solutions, you will find a wealth of knowledge to enhance your ability to use these technologies with maximum effectiveness. Those using these systems must understand their role as the human guardrail of AI, critically assessing the outcomes, making intelligent judgment calls, and ensuring better decisions. Code: FDB3242