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

Jun 01, 2017

Register Free: http://www.chromatographyonline.com/lcgc_w/data

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?


Speaker: Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation 


Date and Time: 

Live: Thursday, 1 June, 2017 | 10 am EDT | 9 am CDT | 1500 BST | 1600 CEST 

After the final airing of the webcast 1 June, 2017 it will be available on demand until 1 June, 2018. 

Sponsor: Waters Corporation 

Register Free: http://www.chromatographyonline.com/lcgc_w/data

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