SOP for Data Backup, STORAGE OF ELECTRONICALLY GENERATED

PROCEDURE FOR ARCHIVING, STORAGE AND RETRIEVAL OF ELECTRONICALLY GENERATED

  1. PURPOSE:

To lay down a procedure for the backup/restoration of electronic data of all computerised systems connected with the instruments/ equipments in Quality Control Department.

  • SCOPE:

This SOP is applicable for electronic data and audit trial generated by all computerised systemsconnected with the intruments/equipments in Quality Control Department.

  • RESPONSIBILITY:
User Department (Quality Control)   : To Prepare, follow and Review the SOP
Quality Assurance : To Review and check the Compliance of SOP
QA Head : To Approve the SOP
  • PROCEDURE:
    • Procedure for Backup:
      • Data backup shall be taken for all the data generated by instruments, which are connected to computers i.e. HPLC, UV, FTIR, SCADA, MELTING POINT etc on Daily/Monthly basis.
      • In Monthly Backup the data is transferred from primary Disk to server through defined script from where the data is transferred Tape media in two copies and one copy shall be kept in fire proof lock and key cabinet at IT office and the second copy at secure place away from Plant premises.
      • For backup data the storage media tape is used and shall be labeled properly. Three Types of backup i.e. Incremental (Daily), and monthly (full). Only Monthly Backup shall be performed in two copies. Incremental (Daily), shall be performed in one copy. Separate storage Media Tape shall be used for Incremental (Daily), Weekly (Full) backup. The record for the storage media shall be maintained by IT Department.
      • Procedure for Backup of FTIR

The backup performed for FTIR is script based.

  • A Script is defined to transfer the data defined on E:\IR along with the log file.
    • The Script is scheduled for every four hours. If script fails due to non working of system then the next scheduled backup shall be considered.
    • In case of instrument idle, Weekly Off / Holidays / Instrument Shutdown, the script will run from the next scheduled time.
    • Procedure Data Restoration of FTIR

The restoration performed for FTIR is manual.

  •  The Administrator shall copy the desired data as per approved request received from the department from tape Media to Restore data folder Empower database server.
    • The Administrator shall login in client machine and copy the restored folder/files from Empower database server to Restore data folder in local client machine.
    • The Administrator shall invite analyst from requisite department to verify the restored data.
    • The analyst shall login in software and open the requisite data from the restored folder / files.
    • The analyst shall verify the data.
    • Procedure for Data Backup of Water Scada System

The Backup Performed for SCADA is script based. 

  • A Script is defined to transfer the data defined on ( Drive-Any Name)along with the log file.
    • The script is scheduled for every four hours. If script fails due to any reason, then the next scheduled backup shall be considered
    • In Case of instrument idle, Weekly Off / Holiday /Instrument Shutdown, the script will run from the next scheduled time.
    • Procedure for Data Restoration of Water Sacada System

The restoration performed for data Scada is manual.

  • The administrator shall copy the desired data as per approved request received from the department from Tape media to Restore data folder Empower Data base server.
    • The administrator shall login in client machine and copy the restored folder/files from Empower database server to restore data folder in local client machine.
    • The administrator shall compare the restored data by comparing the size of the restored data with the original backup data.
    • Procedure for data Backup of melting Point System

The restoration performed for melting point is manual.

  • A Script is defined to transfer the data defined on D:\ BACKUP along with the log file.
    • The script is scheduled for every four hours. If script fails due to any reason, then next scheduled backup shall be considered.
    • In Case of instrument idle, Weekly Off / Holidays / Instrument Shutdown, the script will run from the next scheduled time.
    • Procedure for Data Restoration of Melting Point System

The restoration performed for melting point is manual.

  • The administrator shall copy the desired data as per approved request received from the department from Tape media to Restore data folder Empower Data base server.
    • The administrator shall login in client machine and copy the restored folder/files from Empower database server to restore data folder in local client machine.
  • The administrator shall compare the restored data by comparing the size of the restored data with the original backup data.
    • Procedure for Data Backup of UV

Here two types of backup shall be performed. On is application backup through Class_Agent Manager and other is script baseds backup.

  • Procedure for Data Backup of UV System through script.The first type of backup performed for UV is script based.A Script is defined to transfer the data defined on D:\UV along with the log file.The script is scheduled for every hours. If script fails due to any reason, then next scheduled backup shall be considered.In Case of instrument/Idle, Weekly off / Holiday / Instruments Shutdown, the script will run from the next scheduled time.

The analyst shall compare the print data from the restored folder with the original data print taken in the past

  • Data Backup of Empower Server to tape storage media
    • The Desired data of Empower server is performed on Tape Drive by the software Symantec backup Exec 2020      installed on Empower database server. Two types of backup i.e. Incremental (daily), and Monthly (full) is defined in the Symantec Backup Exec 2020 and shall be performed in two copies. Separate storage Media tape shall be used for Monthly (Full) backup. The record for the storage media tape shall be maintained by IT Department. Incremental (Daily) Backup shall be performed on all working except as this day is scheduled for Weekly. Monthly Backup shall be performed +- 7 days for month in two copies on separate Tapes. One copy shall be kept at IT Office in Fire proof lock and Key. The Second Copy shall be transferred to other location outside factory premises and shall be recorded .The log for the offsite location is maintained.
  • ABBREVIATIONS:

SOP                             :           Standard Operating Procedure

QA                               :           Quality Assurance

QC                               :           Quality Control

nm                               :           Nanometer

µL                                :           Micro liter

UV                               :           Ultra Violet

%                                 :           Percent

mm                              :           Millimeter

ml                                :           Milliliter

  • REFERENCES:

In-house/Manufacturer

  • ANNEXURES:

NA

  1. REVISION HISTORY:
S. No. Document No. with Version No. Superseded Document No. with Version No. Reference Change Request No. Page no. Point No./Section Description of Change
             

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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