Dr Markus Dathe, F. Hoffmann-La Roche AG, Switzerland
Dr Bob McDowall, R D McDowall Ltd., UK
Why Is An Audit Trail and Its Review Important?
When is an Audit Trail not an Audit Trail?
- 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?
Workshop 1: Which CDS Audit Trail to Review?
- What do we look for in an CDS for auditing?
- Pros and cons for event logs and audit logs?
- Audit trail(s)?
- Part 11 compliant CDS – does this help data integrity?
Attendees will be presented with an overview of audit trails within some CDS applications and the contents of each one. Which audit trails should be reviewed and when in the context of the work performed by the CDS?
What are GMP-relevant Data?
Workshop 2: Identifying GMP-relevant Data
- Annex 11 requires that audit trails monitor GMP-relevant data – what are GMP relevant data?
- Critical data?
Attendees will be presented with a list of chromatographic records to identify if they are GMP records and how critical they are to help focus the second person review of audit trail data.
Review of CDS Audit Trail Entries
Workshop 3: Reviewing CDS Audit Trail Entries
- What are we looking for in an audit trail review?
- Process versus system: avoiding missing data integrity issues
- Regulatory requirement is “frequent review” of audit trails
- What do we need to validate and what to check?
- Suspected data integrity violation - What do we need to do?
Attendees will be provided with the output of an audit trail to review and see if any potential issues are identified for further investigation.
Controls to Aid Second Person Review of Audit Trails
- Procedural controls for data review
- 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?