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Audit Trail Review – Procedure and Schedule

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:…………..

Instrument ID Observation Done by Checked by

Remarks

Annexure-II       : Checklist for review of Audit Trail

Instrument Name :                                                                 Instrument ID:

Project/Folder Name  :                                                         Date :

Sr. No.

Parameter Checked

    Observation   (Found satisfactory)

Remark

Yes

No

1 Is audit trail enabled for specific Project/Folder?
2 Is any data file found to be deleted from folder/project?
3 Are there any duplicate file name/Data found?
4 Are any unauthorized changes found in instrument method?
5 Are analysis done in appropriate folder as per respective operation SOP?
6 Are adequate audit trail comment(s) given by the analyst(s)?
7 Are measures for protection of date/time in place?
8 Any non-conformance observed with respect to SOP
9 Verification of user account management
10 Verification of any locked user
11 Privileges Verification
12 Verification of system policy
13 Any other

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Janki Singh: Mrs. Janki Singh is the professional pharmaceuticals Blogger. She has already posted more than #1000 articles on varrious topics at different blogging plateforms. Contact : guideline.sop@gmail.com

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