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Standard Operating Procedure (SOP) for Electronic data backup, restoration, archival, retrieval and scheduled verification of stored data of quality control laboratory.

SOP for Electronic Data Management (Laboratory)

PURPOSE

The purpose of this Standard Operating Procedure (SOP) is;

To provide the procedures for Backup, Restoration, Archival and Retrieval of electronic data generated by Stand Alone/Server based Laboratory Instruments/equipment’s in Quality Control (QC) Laboratories.

SCOPE OF SOP FOR ELECTRONIC DATA MANAGEMENT

This SOP shall be used as such for Electronic Data Management of Stand Alone and server-based systems (Backup, Restoration, Archival and Retrieval) generated by the Quality Control Laboratories at pharmaceutical manufacturing plants.

RESPONSIBILITY –ELECTRONIC DATA MANAGEMENT

The technical staff of the Information Technology (IT) Section shall be responsible :

Create the Projects / Data folder as per schedule.

Implement the backup policy for the electronic data generated by the laboratories as per this SOP.

Perform the backup and archival on a regular basis / as per schedule.

Maintain the backup and archived logs as per this SOP.

Ensure that the backup and archival are successfully completed as per schedule.

Restore or retrieve the data as and when required.

Maintain the data integrity and data security of the backed up and archived data.

Section Head / Head QC shall be responsible :

Initiate the data restoration, archival and retrieval request as and when required.

Ensure that the backup, restoration, archival and retrieval procedure is followed as per SOP for laboratory data.

Head Quality Assurance (QA) shall be responsible :

Authorize the data backup, restoration, archival and retrieval request as and when required.

Periodically review of backup data, restoration, archival and retrieval procedure and related documents to ensure that the procedure is followed as per this SOP.

Ensure the training and implementation of this SOP.

PROCEDURE FOR ELECTRONIC DATA MANAGEMENT

Project/Folder Creation and Maintenance Policy for Electronic Data

Project/Folder Creation in Quality Control Laboratory Instruments :

Create a monthly folder/project on a monthly basis. (Except Calibration Folder)

Create a calibration folder/project on a yearly basis. Folder / Project

Follow the Project/Folder naming or path for calibration as follows :

Calibration\YYYY\INS-ZZZ

Where

YYYY = Stand for Current year

INS-ZZZ = Stand for Instrument ID (Like INS-001)

Monthly folders are part of the yearly folder. Create yearly folders created before starting the year at the end of December or at the time of new system installation.

Make the monthly projects/folders a part of yearly projects/folders.

Project Naming or path for routine electronic data storage (except calibration data)

Follow the project/folder name as given below.

YYYY\INS-XXX\ZZZ

Where:

YYYY       = Stand for Current Year

INS-XXX  = Instrument sort name and ID no. :

Example : HPLC = High Performance Liquid Chromatography

UV    = UV-VIS Spectrophotometer

GC    = Gas Chromatography

Instrument ID : like – HPLC-001, UV-002, GC-003…….

ZZZ         = Stand for firth three letters of a month (i.e. JAN, FEB…..)

eg. for UV visible spectrophotometer having the instrument ID: INS-011 for the year 2019 and month January.

Create a folder (path) as “2019\UV-011\JAN”

Project Availability for Analysis / Review (Electronic Data).

For analysts, make available/accessible only current month projects for analysis.

Make available last month projects for processing/review (if any) up to date i.e. 10th of the current month.

After the 10th of the current month, no previous month projects shall be accessible for analyst/reviewer.

Backup of Standalone Systems where electronic data is stored on the local computer drive:

Perform data backup (Electronic Data) of standalone systems on a weekly basis on the predefined backup folder on the server or directly on the external media and record the activity as per Attachment 1.

Further, the backup of the “predefined backup folder” on the server (if the backup is not taken directly on the external media) shall be taken on external storage media/device as per IT procedure.

Perform the monthly backup as per Attachment 2.

Remove the project/folder from the instrument PC after completion of monthly backup (Except Calibration Folder)

Backup of Standalone (where Electronic data is stored on server drive) and Server Based systems :

In this case, the electronic data is stored directly on the predefined data folder on the server drive.

Take the backup of the “predefined Data folder” on the server on external storage media/device as per the IT procedure.

Electronic Data that are saved directly on the server shall be verified for smooth storage on a monthly basis and record the details as per Attachment 4.

Electronic Data Restoration :

The user department shall fill the request for Data Restoration as per Attachment 3, and take approval with Department Head and Head QA.

User department shall submit the request to the IT department.

The QA Head or designated representatives shall authorize the restoration of electronic data in accordance with the documented incident or request. (Refer Attachment 3).

Documented and tested procedures should be used for restoration.

When the restoration procedure is manual, it should be recorded and signed.

After the restoration of electronic data following verification shall be done to ensure that the restoration done properly (Refer Attachment 2),

Technical: This verification can be auto or manual based on the size of electronic data which is restored vs. backed up.

Analytical: Three sets of electronic data from a test like RS, Assay, DR, etc. from the restored data shall be compared with the officially reported data for those tests i.e. Chromatograms, integration parameters, peaks area, system suitability parameters, and results. The restoration considered successful only if the verification parameters of restored data match with the officially reported data.

Note – Any unusual finding shall be filed as Incident and investigation shall be performed to find out the root cause and establishment of CA and PA as per the current version of respective SOP’s for Laboratory Incident and CAPA.

After completion of the activity, the IT person shall re-backup the folder and removed it from the system where the folder was restored.

QA shall ensure the retrieval activity shall be completed as per SOP.

Verification of backed up data

For Monthly Electronic Data Storage media/devices

Frequency – Verification shall be performed after the monthly backup preferably within a week from the backup.

Technical – Check the monthly backup media/devices to verify that the storage media/devices are working as intended, storage media/devices shall be checked for any technical issues/fault if any. Identify the files for any corrupt data file or any other discrepancy in the storage media/device.

Analytical –

Store two sets of electronic data for test like RS Assay DR etc. from the backup storage media/devices (i.e. from monthly backup storage media/device).

Compare the restored data with the officially reported data for the details like – Chromatograms, integration parameters, peaks, area, etc.

The restoration considered successful only if the verification parameters of restored electronic data match with the officially reported data.

Note – Any unusual finding shall be filed as Incident and investigation shall be performed to find out the root cause and establishment of CA and PA as per the current version of respective SOP’s for Laboratory Incident and CAPA.

For Yearly Electronic Data Storage Media/Devices

Frequency – All yearly backup storage media/devices shall be checked once in six months.

Technical –All yearly backup media/devices shall be checked to verify that the storage media/devices are working as intended, storage media/devices shall be checked for any technical issues/fault if any. Files shall be identified for any corrupt data file or any other discrepancy in the storage media/device.

Analytical –

Two sets of data for a test like RS Assay DR etc. shall be restored from the backup storage media/devices (i.e. from yearly backup storage media/devices).

Compare restored data with the officially reported data for the details like – Chromatograms, integration parameters, peaks, area, etc.

Select these data sets from different sets of available storage media/devices.

e.g. If three years annual storage media/devices are available then the assessment would be 02 sets of analytical document X 03 yearly storage media/devices= 6 data sets.

The restoration considered successful only if the verification parameters of restored data matches with the officially reported data.

Note – Any unusual finding shall be filed as an event and a thorough investigation shall be performed to find out the root cause and establishment of CA and PA.

Archival of the data –

Archival Frequency: During “April” of each year, the projects/folder which is available up to “December” shall be archived.

Archive data verification frequency: Once in a six month as per procedure defined above.

After verification of the archived and the backup data and based on the review of verification reports and findings from archive/backup storage media/device, QA shall take the decision to remove the data from the live server or from the client.

Note: The QA head shall also ensure that the yearly backup tape / external device verification done successfully.

Remove only whole projects that should be removed instead of only project components. (such as results channels, methods, etc.)

IT shall maintain the list of archived projects/folders with an addition of a specified storage media/device number.

Prepare the archive storage media/device in duplicate (i.e. Maintain two storage media/devices for archived data).

Data Retrieval :

The QA Head or designated representatives shall authorize retrieval of data in accordance with the appropriate request (Refer Attachment 3).

After retrieval of data, verify the electronic data as per procedure defined above to ensure that the retrieval done properly.

Storage Media

Use only high-quality storage media/devices with a maximum shelf life for backup and archival.

Perform the Backup/Archival on to suitable media, and media should be used in accordance with the recommendations of the manufacturer.

When choosing and using storage media, the following points should be considered;

Recommended service life

Acceptable environmental condition for storage

Verification, refresh and rewrite requirements

Storage of Electronic Data Storage Media:

All the storage media/devices shall be secured in fireproof safes in a different building than the QC& storage server, this storage media/devices shall be under limited access.

Make available the Yearly backup storage media/devices in duplicate.

Keep only one yearly backup storage media/device at the site.

Second, yearly backup storage media/device shall be kept in secure fireproof safe outside Block or building premises,

Retention Period of Backup and Archived Electronic Data :

Backup Data Retention Period: Life Time

Archived Data Retention Period: Life Time

Data Migration: The data from the backup/archive storage media/devices shall be migrated to new storage media/devices before the expiry of the recommended shelf life of the media.

Note 1: Shelf life/validity of storage media/device shall be mentioned on each storage media/device.

Note 2: At any time point, the QC data shall be available as per the following,

Yearly backup shall be available at the site and the duplicate copy of the yearly backup shall be available at another location / Block / centralized storage location other than the same building/server room.

Archived data shall be available at the site and the duplicate copy of the archived data shall be available at another location.

ATTACHMENTS

Attachment 1 -Weekly Data Backup Log

Year

Month

Period

From: …………… to………………

 

Date of Backup	Project / Folder Name	Size of Folder (KB/MB) before backup	Size of Folder (KB/MB) after backup	Done by	Remark (if any)

 

Attachment 2 -Monthly Data Backup and Archival Log

Year

Month

 

Date	Project / Folder Name	No. of Files before backup	No. of Files after backup	Project / Folder Removed from Instrument PC (Yes / NO)	Done by	Remark (if any)

 

Attachment 3 -Request for Data Restoration

To be filled by the User Department To,                                                                                           IT Department                                                                            Date: ………………. Aristo Pharmaceuticals Pvt. Ltd.   Kindly restore the folder/s as per the below details. Instrument ID : ________________, Folder  Name : ___________________ Reason For Data Restoration : ……………………………………………………………………………    ____________                           ________________                            ____________ Requested by                         Department Head                               QA Head  (Sign/Date)

To be filled by IT Department   Restoration Status :___________Restoration Date : _____________(Complete or Incomplete) Folder re-backup taken on : …………………                     Folder Removed on:…………….…. Remarks (if Any) :…………………………………………………………………………………………………… ___________                            ______________                         ___________              IT Person                             Department Head (IT)                            QA  (Sign/Date)

 

Attachment 4 -Server Based Data Backup Verification Log

Year

Month

Date	Project / Folder Name	Size of Project during last Verification (KB/MB)	Size of Project As on date (KB/MB)	Review Observation of Audit Trail (Data Creation / Transfer to the server)	Done by	Remark (if any)