Dr Markus Dathe, F. Hoffmann-La Roche, Switzerland
Dr Bob McDowall, ECA Data Integrity Working Group, R D McDowall Ltd
Post Conference Workshop Audit Trail Review for Laboratory Systems
Why Is An Audit Trail and Its Review Important?
What is in a Name?
- 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 Audit Trail to Review?
- What do we look for in an application for auditing?
- Pros and cons for event logs and audit logs?
- Audit trail(s) ?
- Part 11 compliant system - does this help data integrity?
Attendees will be presented with an overview of the audit trails within an application and
the content of each log. Which audit trails should be reviewed and when in the context
of the work performed by the laboratory data system?
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 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 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?
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.
- 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?