Post Live Online Training: Case Studies Audit Trail Review for CDS/Laboratory Systems

Post Live Online Training: Case Studies Audit Trail Review for CDS/Laboratory Systems

Course No 18718

This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager". Learn more.

All times mentioned are CEST.


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Dr Markus Dathe, F. Hoffmann-La Roche AG, Switzerland
Dr Bob McDowall, Member of the ECA IT Compliance Interest Group


The involvement of Quality Assurance in ensuring data integrity in GMP regulated laboratories is discussed in both the PIC/S and WHO guidance documents.  However, turning guidance document recommendations into practice can be difficult, especially if members of QA are not familiar with the topics covered in these guides. This two-day, interactive workshop-based course is intended to fill this gap in the training spectrum.  After an introduction covering the scope and regulatory requirements of quality oversight for GMP regulated laboratories there are presentations, Q&A sessions and case studies on the main topics of the course:
  •  Understanding process and record risk by using data process mapping
  •  Controlling master templates and blank forms
  •  Raising and handling data integrity concerns
  •  Data integrity audits
  •  Data integrity investigations
The case studies material is based on real world examples, so that the attendees can gain experience that they can take back to their own organisations.


Data integrity is a major topic in the pharmaceutical industry and organisations supporting it such as contrast research and manufacturing organisations.  The regulatory focus has been in Quality Control and Analytical Development laboratories working to GMP especially since 2012 with the updated FDA Compliance Programme Guide 7346.832 for Pre-Approval Inspections.  This guide has as objective 3 the data integrity audit.  Therefore, it is important that Quality Assurance be aware of the FDA approach as well as ensuring that laboratory activities are under control, compliant and ensure data integrity.

Target Group

  • Managers and staff from Quality Control and Analytical Development Laboratories of pharmaceutical companies
  • Contract Research Organisation and Contract Manufacturing Organisation laboratory personnel
  • Quality Assurance staff involved in reviewing laboratory data or performing data integrity Audits
  • Auditors (internal and external) responsible for performing self-inspections or external audits and needing to understand and assess data integrity

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


What Is An Audit Trail and Why is 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? 
  •  Static data and dynamic data impacts on audit trail functionality
When is an Audit Trail not an Audit Trail?
  •  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?
Case Study 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 one. 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?
  •  What are critical data?
Case Study 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?
Case Study 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?

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