Audit Trail Review Based on Risk Based Approach
Автор: Hitendrakumar Shah
Загружено: 2024-09-07
Просмотров: 2189
Описание:
This training session helps to understand the practical way to implement Audit Trail Review Based on Risk Based Approach.
The audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GXP records.
An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the “who, what, when and why” of the action.
The agenda for the training session is as below;
Importance of topic and Agenda
Know your Trainer
Guidelines- Regulatory Expectations
Brief on Audit Trail review as part of electronic data auditing
Contents of audit trail
Process/ Documentation in the audit trail review and discrepancy handling
Data audit trail and system audit trail
Points to consider as a part of risk assessment
Example of audit trail review in Empower Software 3.8.0
Audit Trail review – Practical steps for implementation
Q&A, Vote of Thanks and contact details
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