Dr Markus Dathe, F. Hoffmann-La Roche AG, Switzerland
Dr Bob McDowall, R D McDowall Ltd., UK
Programme
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?
When is an Audit Trail not an Audit Trail?
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?
Workshop 1: Which CDS Audit Trail to Review?
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?
Annex 11 requires that audit trails monitor GMP-relevant data – what are GMP relevant data?
Critical data?
Workshop 2: Identifying GMP-relevant 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
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 CDS 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?
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
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