3 Replies Latest reply on Sep 18, 2017 10:37 AM by ryoboyle

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

      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 )