Why Is An Audit Trail and Its Review Important?
- Part 11 and Annex 11 / Chapter 4 requirements for audit trail
- Regulatory requirements for audit trail review
- Guidance documents for audit trail review
- Do I really need an audit trail?
Audit trail vs. system log
- Audit trail content
- Log files
- What and when should I review?
- Meaningful audit trails for a meaningful review
Workshop 1: Which Audit Trail to Review?
Attendees will be presented with an overview of the audit trails within an application and the content of each one. Which audit trails should be reviewed and when?
What are GMP-relevant Data?
Annex 11 requires that audit trails monitor GMP-relevant data – what are GMP-relevant data?
Workshop 2: Identifying GMP Relevant Data
Attendees will be presented with a list of records to identify if they are GMP records and how critical they are to help focus the second person review of audit trail data.Examples from production, laboratory and QA examples of GMP relevant data will be provided
Review of Audit Trail Entries
- Guidance for frequent is “frequent review” of audit trails
- Process versus system: avoiding missing data integrity issues when only focussing on a per system review
- What are we looking for in an audit review?
- Suspected data integrity violation - What do we need to do?
Workshop 3: Reviewing Audit Trail Entries
Attendees will be provided with the output of an audit trail to review and see if any potential issues are identified for further Investigation.
Technical Controls to Aid Second Person Review of Audit Trails
- Technical considerations for audit trail review e.g.
- Identifying data that has been changed or modified – how the system can help
- Documenting the audit trail review has occurred
- Review by exception – how technical controls can help
- Have you specified and validated these functions?