SOP for Backup/Restore Analytical Data in Electronic Form

1.0 OBJECTIVE

To lay down a procedure for ensuring proper backup/restore of analytical data, from the computers associated with laboratory equipment.

2.0 SCOPE

This SOP is applicable for the backup/restore of analytical data, from the computers associated with laboratory equipment.

3.0 RESPONSIBILITY

System Administrator

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 PROCEDURE

5.1 Analytical Record Archival

5.1.1 The analytical data is acquired from laboratory instruments through computers running the application software for processing and printing the chromatogram.
5.1.2 The analyst prints the processed data on a paper.
5.1.3 This printed document is then reviewed by the analyst and the reviewer.
5.1.4 The reviewed chromatogram in the paper form with original signature shall be treated as a master copy and same shall be used for taking all decisions pertaining to quality of the material.
5.1.5 The analytical record in paper form shall be archived and preserved for future reference and decision making.
Related: FDA’s Data Integrity Issues during Inspection

5.2 Data Backup and Restore in Computer System

5.2.1 The computer systems associated with laboratory equipment are standalone systems with limited storage space.
5.2.2 Because of this only the current data shall be maintained on the computer system.
5.2.3 Housekeeping activity shall be performed periodically to delete the old data from the computer system so as to ensure the available space for the uninterrupted acquisition of data by the application software.
5.2.4 A log shall be maintained by the system administrator for the above-mentioned housekeeping activity.
5.2.5 System administrator shall back up the current analytical data from primary hard disk to secondary hard disk in the computer system on daily basis.
5.2.6 In the event of the computerized system crash the system administrator shall restore the analytical data from secondary hard disk to primary hard disk.
5.2.7 Restore data in hard disc/shall be maintained and recorded can be produced on demand

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

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