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