Audit Trail Review - A Practical and Compliance Approach

An audit trail review (ATR) is typically a time-consuming, detail-oriented chore to ensure regulatory requirements have been met. It is performed by a second person, who checks to make sure the work has been performed correctly, no mistakes have been made, and the analysis has not been falsified. The review is focused on data integrity and must cover the whole of the analytical process: from sampling to the calculation of the reportable result.

The course is started with two short videos. On video is on Inspection readiness for computerised system and another is on data integrity and audit trail review.

There are three addtional lectures. One lecture is on, electronic data auditing techniques. In the audit trial review context, electronic data plays very important role. So, the different techniques are discussed in this session.

The next lecture is on Good review practices - A risk based approach. As per MHRA guide, the routine data review including audit trail review should be based on risk based approach. So, the last two lectures are focussed on risk based approach for review.

The last lecture is on audit trail review on risk based approach. As, the material is prepared in line with the current guidelines, it will be really benificial to the participants.