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.
This SOP is applicable for all the computers associated with laboratory / other system equipment’s used manufacturing facility of xxx.
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.
- QC Standalone system:
- Carry out data back up in 3 stages, namely weekly, Monthly & Yearly.
- Prepare a weekly folder as per following example on backup server.
- Department ID/instrument ID/Weekly/DDMMYYYY.
- Weekly back up:
- 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.
- Log on to the system.
- Copy all the data, open the weekly folder & paste in the Backup folder made on backup server.
- Monthly Backup:
- Monthly backup shall be taken in first week of subsequent month.
- Create Monthly folder as follows.
- Department ID/instrument ID/Monthly/DDMMYYYY.
- Copy all the data, open the Monthly folder & paste in the Backup folder made on backup server.
- Other System Backup
- Copy all backup required data and Open the shared drive(From Backup server) from my computer and copy his/her data in shared folder
- User must store his/her essential data in mapped shared drive on daily basis or as per requirement.
- Other system mapped drive data backup carry out daily basis as per backup server schedule.
- Yearly Backup:
- Yearly backup shall be taken in first week of January, the procedure for backup shall as follows:
- Log on the system
- Create Yearly folder as follows,
- Department ID/Instrument ID/Yearly/DDMMYYYY
- Copy all the data, open the Yearly folder & paste in the backup folder made.
- After successfully backup send one set of data to head office for offsite backup.
- Offsite backup shall be performed on quarterly basis in a suitable media and shall be send to corporate office.
- 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.
- QC Standalone system:
- Data Archival Procedure:
- 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.
- The data media shall be with following details:
Application software Name, Computer System ID, Archived Data Period, Archived data contents
- Data Backup and verification Procedure:
- Copy all back up folder from all instrument PC in local backup server or portable device.
- Verification of Data backup:
A log shall be maintained to record the data backup process. The log shall carry the following details:
- Date & Time of backup
- Name and Signature of person taking and verifying backup.
- Data backup verification remark.
- Data Retrieval and Restoration Procedure:
- If it becomes necessary to restore the previous data, prior approval of Head Quality Control shall be obtained.
- Only authorized person shall be allowed to restore the data.
- The restored data shall be verified and record for the same shall be maintained.
- If the data is modified, same is to be backed up again and to be placed along with a remark on the device.
- Frequency for the verification of computer data restoration is once in every six months.
Trainer: Head – Information Technology
Trainees: Staff of all Department
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
Annexure I : Record of data backup process
Annexure II : Record of data retrieval and restore backup process
Annexure III : Record of data Transfer process
- REVISION HISTORY CARD: