What you'll learn
The participants will understand the concept of audit trail review with learning from expectations by different regulators
Practical implementation of audit trail review based on risk based approach
Compliance evaluation and brief expectations about audit trail review so that protect the organisations from potential data integrity observations
The participants will develop the different thought process about the audit trail review which will help for compliance
Requirements
The participants should focus and give attention to the learning
Description
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.
Overview
Section 1: Introduction
Lecture 1 Introduction
Lecture 2 Audit Trail Review
Lecture 3 Electronic Data Auditing Techniques
Lecture 4 Good Review Practices - A Risk Based Approach
Lecture 5 Audit Trail Review Based on Risk Based Approach
Pharmaceutical professionals, quality control, quality assurance, investigation team members, auditors, compliance team, managers and also subordinates




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