Blog

Standard Operating Procedure (SOP) for Audit Trail Review for the application software on computer system associated with laboratory instruments.

Audit Trial Review

1.0   Objective :

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

2.0   Scope :

• This SOP is applicable to Quality Control Department at the pharmaceuticals drug manufacturing plants.

3.0   Responsibility :

• Reviewer QC/QA/IT shall be responsible for-

• Follow the Procedure for checking the audit trail.
• Record the observation during review.
• To report any abnormal change to head QC/Designee

• Head QC/Designee shall be responsible for-

• Final Review of the the audit trail record
• Investigation of any abnormal change

4.0   Procedure for Audit Trail Review:

• Audit trail shall be checked for all the application software on computer system associated with laboratory instruments with a team of QC, QA and IT members.
• For operation, follow the respective SOP.
• QC reviewer shall open the software of the instrument with his/her own password; reviewer can seek the help of administrator if required.
• Reviewer shall do the complete audit trial review of the respective instrument and if there is any observation found then the same shall be documented in Annexure I.
• The review of application software on computer system associated with laboratory instruments  shall be done but not limited to as per Checklist for review of audit trial – (Annexure II).
• Analytical Data Reviewer shall verify the printed data with soft data in case any ambiguity observed.
• Reviewer shall review the audit trail of instrument as a part of review of electronic data as per applicability and have details of change, which, who, when and why?
• Reviewer shall record the observation in checklist for review (Annexure II).
• After verification of data reviewer shall enter the details in record for checking of audit trail (Annexure-I) for all respective instrumental project.
• Any abnormality observed during the review of audit trail shall be informed to Head QC /Designee.
• Checklist for review of audit trail & record for checking of audit trail shall be finally checked by Head QC /designee.
• Any abnormal change found during review of audit trail shall be recorded, investigated as per the SOP of deviation control.
• Frequency of Review: At least once a week.

5.0   Annexure for Audit Trail Review :

Annexure-I        : Record for Checking of Audit Trail

From                                Date: …………….                            to                                 Date:…………..

Annexure-II       : Checklist for review of Audit Trail

******************************************END*****************************************