Full-day pre-course session Audit Trail Review - Live Online Training
Tuesday, 27 October 2026 9 .00 - 17.15 h
Course No. 21647
Speakers
Dr Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity Guide – Version 3”.
We offer you a discount of EUR 600 if you book this training course together with the course "Data Integrity - Requirements for a GMP-compliant Data Life Cycle" from 28-30 October 2026.
Target Group
These Live Online Trainings are designed for
managers and staff from health care industries
managers and staff from suppliers
auditors who are responsible for the organisation and execution of Audit Trail (Reviews) and Data Integrity in their companies.
Objectives
You will learn the current regulatory requirements and regulatory expectations for an audit trail (review)
All GMP-relevant data (changes and deletions) should be audit trailed – you will learn how to identify GMP-relevant data
Event and audit logs: you will understand the differences between and what the regulators expect
How should an audit trail review be performed? You will get familiar with the content and the frequency of an audit trail review
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?
Audit Trail vs. System Log
Audit trail content
Log files
What and when should I review?
Meaningful audit trails for a meaningful review
Case Study / Faciliated Discussion: 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?
Case Study / Faciliated Discussion: 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?
Case Study / Faciliated Discussion: 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?
Further Information
Technical Information
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you Need to participate in our events and you can check if your System meets the necessary requirements to participate. If the Installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT)
Non-ECA Members EUR 1,290 ECA Members EUR 1,090 APIC Members EUR 1,190 (does not include ECA Membership) EU GMP Inspectorates EUR 645 The conference fee is payable in advance after receipt of invoice.
We offer you a discount of € 600 if you book this training course together with the course "Data Integrity - Requirements for a GMP-compliant Data Life Cycle " from 28-30 October 2026 here.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
