On Wednesday 31 May 2023 DARQA hosted a theme day addressing the practicalities of audit trails and audit trail reviews in pharmaceutical and medical information management systems.

The session was based on questions from the audience from previous DARQA ICT webinars and theme days, we examined various aspects of audit trail reviews. It was well attended by approximately 30 attendees, 10 in-person and 20 online, and we had an interesting moment working together on a Failure Mode Effect Analysis (#FMEA) risk assessment on audit trail functionality.

Special thanks to Frans Boeijen for his input and collaboration during the session!

During the interactive session, we explored IT systems audit trails, focusing on the review of audit trails and how core principles of data integrity, like #ALCOA+, relate to those. The program included a demonstration of audit trails, workflow management, a combined #GMP/#GLP #LIMS database, and an examination of the data that should be included in an audit trail and how it can be reviewed.

We also discussed various related subjects, such as verification of user rights, single sign-on credentials, and the alteration or deletion of data within audit trails for data anonymization as a #GDPR requirement. Additionally, we explored different types of audit trail reports and their review processes.

After talking about audit trails and their review in detail, we moved on to the topic of risk assessments by doing an FMEA and talking about the concepts of process mapping (the foundation for computerized systems validations) and asset/data/threat mapping (the foundation for information security).

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