SOP for Audit Trail Review

Objective

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

Scope

This SOP is applicable to the Quality Control Department at PharmaInfo 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.

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• 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

ALSO READ: SOP for Review and Approval of Analytical Raw Data