Audit Trail Review often begins with one overwhelming question: What exactly am I supposed to look at?
In today’s GxP environment, the amount of data, records, system events, and audit trail entries can quickly become difficult to manage. Simply “checking the audit trail” is not enough — but where should the review start, and how can it be performed in a meaningful and risk-based way?
In this webinar, Tanja and Sarah, will take you on a practical journey from the initial feeling of data overload to a structured approach for Audit Trail Review. Together, we will explore how ICH Q9 quality risk management can support the process, why understanding the data flow is essential, how audit trail functionality contributes to data integrity, and how risk assessment helps define what really matters.
Along the way, we will show why Audit Trail Review is not an isolated activity, but an important part of the overall Quality Management System. We will also share practical ideas on where AI can support specific steps — from handling large volumes of information to identifying patterns and supporting risk-based decision-making.
Join us to discover how Audit Trail Review can become more focused, more efficient, and better integrated into your data integrity strategy.
Sarah Wittmar is a Specialist at GxP-CC with deep expertise in Data Integrity, validation and pharmaceutical quality topics. She supports clients when data, system or process-related risks need to be understood, structured and translated into...
Dr. Tanja Küssau is a Data Integrity and Compliance expert specializing in Data Governance, and Risk Management in the pharmaceutical industry. She has led multi-site compliance projects, ensuring alignment with regulatory requirements e.g. from...