SOP on Backup / restore and archive of analytical data in electronic form
Objective: To describe the procedure for backup / restore and archive of analytical data in electronic form.
Scope: This SOP is applicable for backup / restore and archive of analytical data in electronic form in quality control laboratory.
Responsibility: QC Executive or Nominee & QA Officer and Above
Accountability: Head-QC & Head-QA
Procedure: QC Executive / Nominee shall prepare list of instruments along with software for which backup of analytical data shall be taken as per Annexure.
Backup of Fortnightly Data:
QC Executive / Nominee shall take backup of Fortnightly data from primary drive to pre – defined secondary drive and to external hard disc. Primary Drive and Secondary Drive (to which fortnightly data shall be stored) shall be mentioned in Annexure.
Assign Id. No. to external hard disc as QCHRD-XX, where XX is the sequential number i.e. 01, 02.
Back up path for external hard disc shall be; External hard disc → Year →Month → Individual instrument Id. No. → Analytical data.
QC Executive / Nominee shall create ‘year’ folder, named as ‘YYYY’, where YYYY is for year.
‘Month’ sub folder shall be created on monthly basis and named as ‘XXX’, where XXX denotes first three letters of the month.
‘Instrument Id. No.’ sub folder shall be named as actual instrument Id. No. of the instrument.
Primary drive to external hard disc data backup process shall be maintained.
External hard disc shall be kept under the custody of QC Head.
Primary drive to secondary drive data backup process shall be maintained.
Monthly Archival of Data:
Data from secondary drive shall be archived on DVD on monthly basis and activity shall be recorded.
Note: Month shall be considered from first day to last day of the calendar month.
DVD shall be labeled as per following pattern; e.g. SM/XXXXX-ZZ/MM/YY
Where; SM denotes Storage media , XXXXX – Instrument Id., ZZ -Number……01, 02…… ,MM – Month ,YY- Year….07, 08, 09…
Monthly archival shall be completed within 15 days of next month.
The Data Storage media carrying the archived data shall be handed over to QA department.
QC Executive / Nominee shall ensure that primary drive and secondary drive of each system shall not contain data older than two months prior to current month at the time of monthly archival.
The Data Storage media shall be labeled for identification with following details:
Instrument Name & Id. No., Computer Id. No., Archived Data Period.
Verification of Archived data:
QC Executive / nominee shall verify the integrity of the archived data from primary drive to secondary drive or in DVD and in hard disk w.r.t the data lying in primary drive and record shall be kept.
QC Executive / nominee shall restore archived analytical data from DVD & hard disk and select randomly any set of analysis, open and compare it with the original hard copy of the same to check the data integrity and record shall be kept as per the respective format for verification of data integrity.
Incase where the analytical data is directly accessible from DVD / hard disk, through application software, there is no need to restore data in primary drive. Verification shall be done on DVD or hard disk directly.
QC Executive / nominee shall check the data integrity of the archived data of the January and June month of every year, after every 6 months for 5 years and record shall be kept as per the respective format for verification of data integrity.
A Person shall maintain logbook for received data media.
Data Retrieval and Restoration Procedure:
If it becomes necessary to restore the previous data, prior approval of Head – QA shall be taken.
Only QC Executive / Nominee shall be allowed to restore the data.
Log for restoration of data shall be maintained.
Data storage media shall be returned to the QA department.
Backup/ Restore Failure:
If any error or failure is reported in backup or restoration procedure, QC Executive / Nominee shall contact local InfoTech for problem solving.
Vendor support may be sought in cases where problem of backup / restoration failure could not be solved. Further usage of system shall be temporarily stopped till problem is resolved.
All backup and restore failures shall be recorded in remarks column of respective records.
Preservation of Records: All monthly archived data along with records shall be preserved for a period of 5Years.
Precautions for Record Keeping:
All storage media shall be kept in a proper cover to avoid scratches.
Storage media shall be kept within a flame proof cabinet.
Storage media shall be kept within controlled environmental conditions.
Storage media shall be kept in vertical position.
List of Annexures :
- List of Instruments for which Back up to be taken
- Record Log for Data Backup Process (Fortnightly) (For Primary drive to secondary drive)
- Label of Data Storage Media
- Verification record for archived data from one drive to another drives
- Record for Received Data Storage Media
- Data Retrieval and Restoration request
- Records of Retrievals of Backup Data
- Record Log for Data Backup Process (Fortnightly) (For primary drive to external hard disc)
- Verification of data Integrity for HPLC / GC
- Verification of data Integrity for UV-visible Spectrophotometer
- Verification of data Integrity for Polarimeter
- Verification of data Integrity for FTIR
- Verification of data Integrity for TOC analyzer