ON-DEMAND WEBINAR: A Risk-Based Approach to Reviewing Electronic Chromatographic Data and Audit Trails with Data Integrity in Mind

Library Number:
Heather Longden
Content Type:
On Demand Webinar
Content Subtype:
Compliance and Regulatory
Related Products:

Event Overview:
Since Annex 11 first raised in regulation the need for audit trail review, there has been much discussion in industry about how to ensure that information contained in electronic audit trails is reviewed along with the actual data and other meta data. Amongst the plethora of data integrity guidances issued by regulatory authorities, there appears to be a mixture of expectations, including some truly non risk-based approaches indicating a need for 100% review. In many companies audit trail review always formed a part of any data review SOP. Some companies have since attempted to create a separate audit trail review SOP, without much thought to the quality and value this exercise adds. Additionally there is a struggle to adequately “document” audit trail review, which leads to the wider concern—how to adequately document any kind of quality review. What exactly does “signing a document” indicate?

Key Learning Objectives:

This webcast will:

  • Reexamine the purpose and definition of audit trails
  • Review the various released and draft guidances for this topic
  • Discuss the kinds of records that make up an electronic audit trail and other records that might be created
  • Address the level of knowledge needed to effectively review audit trails
  • Look at the challenges and practical approaches of the actual review process and the method documentation of that review

Who Should Attend:

  • Regulated companies (pharmaceutical, food, environmental)
  • Laboratory directors, managers, and analysts
  • Information technology professionals supporting laboratory applications: managers, business system analysts
  • Quality Assurance professionals