SOP for Audit Trail and Backup of Shimadzu IR Spirit-X FTIR

PURPOSE

To lay down a procedure for the Audit Trail and Backup of the FTIR Spectrophotometer, Model: IRSpirit-X, Make: Shimadzu

SCOPE

This SOP applies to the Audit Trail and Backup of the FTIR spectrophotometer, with the model IRSpirit-X and the make Shimadzu.

RESPONSIBILITY

• QC Analyst: Audit Trail and Backup of an instrument as per SOP.
• Senior Analyst: Reviewing of recorded data and implementation of the SOP.
• Manager QAD/QCD: Approval and responsible for implementing the SOP.

PROCEDURE

Monthly Audit Trail Review

• QC analysts shall conduct an audit trail review once a month.
• Record the observation(s) in the format ‘Monthly Audit Trail Review Record for FTIR Spectrophotometer’ as per the Attachment.
• Perform the audit trail by login into the LabSolutions software in the Administration tab  ➡➡   Log Browser tab as shown below:

ALSO READ: Operational Qualification of UV Spectrophotometer UV 1800

• Verify the system Administration/Application/User Authentication logs for any deviation or incident for the preceding month.

• All the identified events must be justified with proper reasons.
• If any unacceptable events are observed during the review, the same shall be investigated.

Backup

• Login respective instrument computer and then login to the LabSolutions software.
• Go to the ‘Administration’ tab and click on the ‘Backup’ icon to initiate the backup.
• The ‘Backup – Select Target’ window opens, check the data which needs to be backed up, enter the reason for backup and click on ‘Next’.
• The Backup-Condition settings window opens, choose the destination.

• Keep the ‘Divide the backup folder’, ‘Period of Backup’, ‘Set password for Backup database’ and ‘Clear source data after backup’ options unchecked.
• Click on ‘Next’.
• The Backup-Confirmation window will open, click on ‘Start’.

ALSO READ: SOP for Operation of Shimadzu IRAffinity-1S FTIR

• After completion of the backup, a ‘Backup has been completed successfully’ message will display, click on ‘OK’.

• Once the backup is completed, copy the backup file to a respective external device.

ANNEXURES

Monthly Audit Trail Review Record FTIR Spectrophotometer

REVISION HISTORY

Nil

ALSO READ: Installation Qualification of FTIR (IR Affinity-1S)