by 1.0 OBJECTIVE
To lay down the procedure forbackup, archival, restoration and challenge test of electronic data.
2.0 SCOPE
This procedure is applicable for thebackup, archival, restoration and challenge test of electronic data generated in Quality Control Department
3.0 RESPONSIBILITIES
QC person/IT person: To follow the SOP.
Head QC: To review and implement the SOP.
IT Dept.: To collect backup of data and ensure storage.
4.0 DISTRIBUTION
Master copy : Quality Assurance Department
Controlled Copy – 1 : Quality Control Department
Controlled Copy – 2 : IT Department
5.0 PROCEDURE
Backup: A snapshot of an active system user and system data that is created for restoration purposes in the event of data loss. Backups are created and disposed according to an established schedule.
Archive: The transferring of on-line data to a separate storage media. The purpose of archiving is to free space on the on-line system, while maintaining the ability to recover old data.
Restore: The restore process places the backup copy of lost application or user data back on to the designated system.
Data backup procedure:
- Regular backup shall cover the electronic data generated in QC laboratory during the analysis.
- Back up data for HPLC instruments, on client server shall be backed up automatically through online server and NESS drive .
- Back up data for instruments, on standalone computer shall be backed up automatically through online server and NESS drive .
- The frequency for the hot backup shall be daily and cold backup shall be weekly.
- IT person shall monitor the backup of electronic data generated.
- For instruments other than HPLC, the data shall be saved in the month wise projects/folders in order to organize the data in easily retrievable format.
- Backup of electronic data shall be taken by IT person within the first three days of every month (±3 days) in the presence of QC person.
- All the backup of electronic data is done by the IT person through administrator login.
- No one shall have the access to the backup folder. If required management representative/QA Head or his designee can access the data.
- IT person shall make a duplicate copy of the backup data, in a CD /DVD/Hard disk and label them with a permanent marker.
- One copy shall be kept at site and the other shall be kept at head office.
- Monthly backup activity of analytical data shall be documented .
- The CD/DVD/Hard Disk containing archived data shall be preserved for a period of minimum5years from the date of backup.
Restoration and challenge test of backup data:
- Restoration of backup data shall be performed by IT administrator on each instrument once every three months±7 days.
- For the challenge test of electronic backup data, QC executive shall select any one data from the restored projects for all the instruments.
- QC personnel shall take a printout of the selected data and verify the raw data with respect to the original hard copy of respective data.
- Head QC or designee shall approve the challenge test.
- Restoration and challenge test of backup data shall be performed to confirm the integrity and reliability of data over the storage time with the original raw data. A record shall be maintained .
