Post Conference Workshop Audit Trail Review for Laboratory Systems

20 June 2018, Berlin, Germany

Course No. 16641

header-image

Speakers

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

Objectives

eir own organisations.

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?
  • 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?
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 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?
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 training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023