Practical applications of Data Integrity and Audit Trail Review


Since 2015, With the intro of the Data Integrity guidelines and the focus on data management and security, the audit trail has become a primary focus of inspections. Understanding your Audit trail and the ability to review the data contained in it is now essential to compliance. In this 1hr workshop with hope to demystify the audit trail by providing recommendations and examples of good vs bad audit trails and providing tools to evaluate your systems for inspection readiness.

Session learnings

Identify few bullets for attendees to understand what they will take from your workshop

  • ​Leveraging the supplier’s experience and recommendations in understanding the audit trail functionality and approaches for validation.
  • ​Importance of details of user requirements and user acceptance testing of audit trail functionality
  • ​Review of the audit trail: System review vs Data review & Event logs vs. audit logs
  • ​Identify and avoid typical pitfalls



Who should benefit

Lab Managers & Directors, Laboratory IT professionals



R Lutskus Paperless Lab Academy

Name: Robert Lutskus

Title: Associate Director Commercial Operations, Informatics

Email: Robert.lutskus@lonza.com

LONZA Paperless Lab Academy

MODATM is a comprehensive platform for environmental, utility and product monitoring, combining automated scheduling, workflows, mobile data acquisition, device integration, and visual analytics. It eliminates paper-based monitoring and testing that can be expensive, error-prone, time and labor- intensive, therefore enhancing Data Integrity, reducing timelines and potentially saving clients QC costs.