SOP on Electronic Data Backup Management System

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1.0 Objective

To lay down a procedure for electronic data backup management system.

2.0 Scope

This standard operating procedure is applicable at pharmaceutical manufacturing plant.

3.0 Responsibility

3.1 IT personnel shall be responsible for taking the backup.

3.2 IT personnel shall be responsible for retrieving the tapes form other location.

3.3 Officer/Executive IT shall be responsible for destruction of backup tapes.

3.4 Head-QA/Designee shall be responsible for the compliance of the SOP.

4.0 Abbreviations and Definitions

SOP                        –              Standard Operating Procedure

IT                            –              Information Technology

QA                          –              Quality Assurance

QC                          –              Quality Control

5.0 Procedure

5.1 For Whole Plant

5.1.1 Frequency: Monthly

5.1.2 Backup shall be taken by IT personnel in a new tape.

5.1.3 Tape shall be assigned with a unique eleven digit alphanumeric characters.

5.1.3.1 First Character shall be “P” denoting Pharmapathway.

5.1.3.2 Second character shall be “B” representing Backup.

5.1.3.3 Third and fourth character shall represents code assigned to the department e.g. WH for whole plant and QC for Quality Control and so on.

5.1.3.4 Fifth, Sixth and Seventh character shall denotes the serial number of the tape.

5.1.3.5 Eighth character shall be a dash “-”.

5.1.3.6 Ninth and tenth character shall be the last two digits of the calendar year e.g. 15 for 2015 and 16 for 2016.

5.1.3.7 Eleventh character shall be “A” for Tape 1 and “B” for tape 2.

5.1.3.8 Tape 1 shall be retained at plant while tape 2 shall be retained with IT department at other locations of pharmapathway in fireproof area.

5.1.3.9 Each department personnel shall store the data (Data whose backup is to be taken) in Z drive of their system.

5.1.3.10 IT personnel before taking the backup shall intimate all the users well in advance regarding the date of taking the back by electronic means.

5.1.3.11 IT personnel shall affix the number on the tape in the space already provided on the tape.

5.1.3.12 IT personnel shall record the number allotted to the particular tape on Annexure-I.

5.1.3.13 IT personnel then take the backup using NT backup software.

5.1.3.13.1 Backup procedure: Choose the network drive to backup with verification option

5.1.3.13.2 After completion of backup, check the automated reports for any error.

5.1.3.13.3 On finding the error, replace the faulty tape with a new tape.

5.1.3.13.4 Assign the same number to the new tape.

5.2 For QC department

5.2.1 Frequency: Monthly

5.2.2 Numbering procedure for the tapes shall remains as per point number 5.1.3.

5.3 Storage of the backup data

5.3.1 Every backup shall be taken in doublet; Tape-1 shall be retained at plant under the authorization of Head-QA in a separate fireproof, lock and key arrangement, while Tape-2 shall be retained under the same conditions under the custody of Head-IT/Designee at other location.

5.3.2 Tape 2 shall be retrieved from IT personnel prior to destruction; also both tapes shall be destroyed at the same time.

5.3.3 Every tape shall be retained for a period of not less than six years, after six years destruction of the same shall be done under the supervision of Head-QA/Designee and Head-IT/Designee.

5.3.4 Destruction record shall be retained with QA documentation cell.

Note: In case some data has lost from any system; the concerned department head/designee (In absence only) shall raise a request (Annexure-III) and send the same to Head-QA/Designee (In absence only) for the approval with proper justification; only after the approval from  QA, Head-IT/Designee shall upload the required data to the user system

Note: Backup shall be taken by IT personnel through single user id i.e. from Administrator login id only.

6.0 Forms and Records

6.1 Electronic data backup record        –              Annexure-I

6.2 Destruction record                          –              Annexure-II

6.3 Request form                                  –              Annexure-III

7.0 Reference (If Any)

8.0 Distribution

8.1 Master copy                                             –              Documentation Cell (QA)

8.2 Controlled Copies    –         Quality Assurance, Information technology and Quality Control

9.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

Annexure-I

Electronic Data Backup Record

S.No.             Tape Number Backup    Date Backup taken by

(IT personnel)

Verified by

(QA Personnel)

Serial Number

of the tape

Number allotted by IT personnel
           
           
           

 

Annexure-II

           DATA DESTRUCTION RECORD

 

Date

 

Tape Number

 

Due Destruction Date

 

Destroyed by

 

Verified by

 

Remarks

 
 

Annexure-III

Request Form

 

For reloading the data in the system

From: Concerned department

Name                          :           ___________________________                                         

Designation                :           ___________________________

Department                :           ___________________________

Sign. /Date                  :           ___________________________

Justification for reloading and reasoning for data lost:

______________________________________________________________________________________________________________________________________________________________________________

Approved By

Head-QA/Designee                                                               

Name                          :           __________________________

Sign. /Date                  :           __________________________

Data Reloaded By

Head-IT/Designee

Name                          :           ___________________________

Sign. /Date                  :           ___________________________

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