AnsweredAssumed Answered

Audit Trail in OpenLabCDS: Review accoriding to Eudralex Volume 4 Annex 11  (OpenLAB CDS ChemStation & EZChrom)

Question asked by testuser on Mar 28, 2016
Latest reply on Sep 18, 2017 by ryoboyle

Hi everyone,

 

According to Eudralex Volume 4 Annex 11 a procedure for the review of audit trails related to GxP relevant data changes has to be established in the pharmaceutical industry. Currently 2 major problems exist.

  1. The Audit Trail is divided in different Log-files and most are not searchable. Additionally there is no possibility to sign the review.
  2. What has to reviewed, how often and when? Do we need to review the Sequence Audit Trail prior to the release of material or is the review of the entry log every year sufficient?

 

Thank you.

- Z.S.

 

(originally posted in OpenLAB Forum: https://zohodiscussions.com/openlabcdsforum#Topic/68030000000041007

2012 September 14 )

Outcomes