Get the latest updates from us for free
Android App

SOP for Backup/Restore Analytical Data in Electronic Form


Standard operating procedure to take backup of analytical data in computers and maintenance of electronic data.

1.0  OBJECTIVE

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

2.0  SCOPE

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

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 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 equipments 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 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 backup 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 produce on demand

6.0  ABBREVIATIONS

6.1  SOP - Standard Operating Procedure
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


Be the first to comment!

Post a Comment