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||
Annexure-II : Checklist for review of Audit Trail
|Instrument Name : Instrument ID:
Project/Folder Name : Date :
Observation (Found satisfactory)
|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|
|12||Verification of system policy|