SOP for Backup & Restoration

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  1. OBJECTIVE:

The purpose of this SOP is to lay down the procedure to ensure proper backup/restore and archival of analytical data / Other system data, in electronic form, from the computers associated with laboratory / other system equipment’s.

  1. SCOPE:

This SOP is applicable for all the computers associated with laboratory / other system equipment’s used manufacturing facility of xxx.

  1. RESPONSIBILITY:

Authorized designee of IT shall be responsible for preparation of SOP & backup & restoration of data. 

Head IT shall be responsible to review the SOP & to ensure procedure is carried out as per SOP. 

Head Quality assurance shall be responsible to approve the SOP and ensure its proper implementation.

  1. PROCEDURE:
    1. QC Standalone system:
      1. Carry out data back up in 3 stages, namely weekly, Monthly & Yearly.
      2. Prepare a weekly folder as per following example on backup server.
      3. Department ID/instrument ID/Weekly/DDMMYYYY.
      4. Weekly back up:
      5. On the date 07, 14 & 21 of every month, transfer the data for weekly back up as follows, in case of any non-working day on these date, the backup shall be taken on next working day.
      6. Log on to the system.
      7. Copy all the data, open the weekly folder & paste in the Backup folder made on backup server.
      8. Monthly Backup:
      9. Monthly backup shall be taken in first week of subsequent month.
      10. Create Monthly folder as follows. 
      11. Department ID/instrument ID/Monthly/DDMMYYYY.
      12. Copy all the data, open the Monthly folder & paste in the Backup folder made on backup server.
      13. Other System Backup
      14. Copy all backup required data and Open the shared drive(From Backup server) from my computer and copy his/her data in shared folder
      15. User must store his/her essential data in mapped shared drive on daily basis or as per requirement. 
      16. Other system mapped drive data backup carry out daily basis as per backup server schedule.
      17. Yearly Backup:
      18. Yearly backup shall be taken in first week of January, the procedure for backup shall as follows:
      19. Log on the system
      20. Create Yearly folder as follows,
      21. Department ID/Instrument ID/Yearly/DDMMYYYY
      22. Copy all the data, open the Yearly folder & paste in the backup folder made.
      23. After successfully backup send one set of data to head office for offsite backup.
      24. Offsite backup shall be performed on quarterly basis in a suitable media and shall be send to corporate office.
      25. For sending the offsite backup, portable hard drive or CD/DVD shall be sending through gate pass system as per annexure III and shall be recorded.
  1. Data Archival Procedure:
    1. Send one copy to Corporate Office for archival in Portable hard drive or CD/DVD media and another copy keep in fireproof cabinet at location.
    2. The data media shall be with following details:

Application software Name, Computer System ID, Archived Data Period, Archived data contents

  1. Data Backup and verification Procedure:
    1. Copy all back up folder from all instrument PC in local backup server or portable device.  
    2. Verification of Data backup:

A log shall be maintained to record the data backup process. The log shall carry the following details:

  1. Date & Time of backup
  2. Name and Signature of person taking and verifying backup.
  3. Data backup verification remark.
  1. Data Retrieval and Restoration Procedure:
    1. If it becomes necessary to restore the previous data, prior approval of Head Quality Control shall be obtained. 
    2. Only authorized person shall be allowed to restore the data.
    3. The restored data shall be verified and record for the same shall be maintained. 
    4. If the data is modified, same is to be backed up again and to be placed along with a remark on the device. 
  2. Frequency for the verification of computer data restoration is once in every six months.  
  1. TRAINING:

Trainer:   Head – Information Technology 

Trainees:  Staff of all Department

  1. DISTRIBUTION:

Controlled Copy 1 :  Head of Department – Quality Assurance

Controlled Copy 2 :  Head of Department – Information Technology 

Controlled Copy 3 :  Head of Department – Quality Control

Original Copy:   Quality Assurance

  1. ANNEXURE(S):

Annexure I             :  Record of data backup process

Annexure II            :  Record of data retrieval and restore backup process 

Annexure III          :  Record of data Transfer process

  1. REFERENCE(S)

 Nil 

  1. REVISION HISTORY CARD:

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