Post Conference Workshop Audit Trail Review for Laboratory Systems
20 October 2017, Barcelona, Spain
Course No. 16314
Speakers
Dr Markus Dathe, F. Hoffmann-La Roche, Switzerland
Dr Bob McDowall, ECA Data Integrity Working Group, R D McDowall Ltd
Programme
Post Conference Workshop Audit Trail Review for Laboratory Systems
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?
What is in a Name?
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?
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 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?
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 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?
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more
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Seminar Programme as PDF