Audit trial review

what is the topics we must review in audit trial before release

You should check following aspects as per 21 CFR part 11 (USFDA) or Eudralex volume-4, Annexure-11 requirements of Electronic data handling and CSV,

  • Whether Audit trail function was enabled throughout the analytical work (For example:- HPLC Analysis)
  • Does audit trail indicate any change(s) made in the electronic data, calculations, chromatograms, integration parameters, Mnual integration etc.
  • If yes, then who made those changes should be visible in the Audit trail
  • Reason for change(s)
  • Date and time when the changes were made, if any (Date, Time stamp)
  • Approval of supervisor for those changes through his / her electronic signature or comments in the remarks section
  • Review of Audit trails by QC supervisor (100% basis)
  • Review of Audit trails by QA (On sample basis, for exampe 20% data)
  • Final review remarks by QC supervisor and then QA Auditor