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SOP for Audit Trail Review

Objective
To lay down a procedure for Checking of an audit trail for the application software on a computer system associated with laboratory instruments.

Scope
This SOP is applicable to Quality Control Department at Pharmasky Ltd.

Responsibility
The QC/QA/IT reviewer is responsible for following the procedure for 
  • Examining the audit trail.
  • During the review, make a note of the observation.
  • Any abnormal change must be reported to the head QC/Designee.
  • The following are the responsibilities of the Head QC/Designee:
  • Final examination of the audit trail record
  • Examination of any unusual change

Procedure
  • The audit trail for all application software on the computer system associated with laboratory instruments must be examined by a team of QC, QA, and IT members.
  • Follow the corresponding SOP for operation.


  • The QC reviewer must use his or her own password to access the instrument's software; if necessary, the reviewer may seek assistance from an administrator.
  • The reviewer shall conduct a thorough audit trial evaluation of the respective instrument, and any observations discovered shall be reported in Annexure I.
  • The review of application software on a computer system associated with laboratory instruments shall be performed in accordance with the Checklist for audit trial review - (Annexure-II).
  • In the event of ambiguity, the Analytical Data Reviewer must compare the printed data to soft data.
  • The reviewer shall examine the instrument's audit trail as part of a review of electronic data based on applicability and have details of the change, which, who, when, and why?
  • The observation must be recorded in the checklist for review by the reviewer (Annexure II).
  • Following data verification, the reviewer shall include the details in the record for audit trail checking (Annexure-I) for all respective instrumental projects.


  • Any anomaly discovered during the audit trail review must be reported to the Head QC/Designee.
  • The checklist for reviewing the audit trail and the record for checking the audit trail must be reviewed and approved by the Head QC/designee.
  • Any abnormal change discovered during the audit trail review must be documented and investigated in accordance with the deviation control SOP.
  • Review frequency: at least once a week.


Annexure
Annexure-I: Record for Checking of Audit Trail
Annexure-II: Checklist for review of Audit Trail


Revision History
Nil


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