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List of Protocols

1.0 INTRODUCTION

The [System Name] ([Short System Name] hereinafter) is installed and operating in the [Department Name] of [Client Name] (from now on [Client Code]), [Site Name] site. The system is used for managing the [Instrument Name] (Id [System Code]) instrument.

[Client Code] decided to start a Validation project for the [Short System Name] System which will provide documented evidence of the system compliance to the quality specification and regulatory requirements for GMP critical systems.

2.0 PURPOSE

The purpose of this Validation Plan (VP) is to detail the activities to be executed at [Client Code], [Site Name] site for the Validation of the [Short System Name] system.

This plan will address following tasks:

  • Provide a general system overview

  • Define the Validation strategy to be applied based on Risk Analysis

  • Determine the deliverables to be produced for each activity

  • Identify the validation team along with the responsibility for the completion of each activity

  • Define the procedures for validation testing (Test Plan Procedure, Annex 1)

3.0 SCOPE

This document applies to the validation life-cycle of [Short System Name] System installed [on the Workstation ID] in the [Department Name] of [Client Code] and controlling the [Instrument Name] (Id [System Code]) instrument.

4.0 SUPPLIER DESCRIPTION

[Insert a description of the SW system supplier].

[Supplier Name] and [Client Code] have successful and long lasting relationship regarding a wide range of laboratory instruments hence supplier qualification requirement is considered fulfilled.

5.0 SYSTEM OVERVIEW

[Short System Name] is the application that controls the [Instrument Name] (Id [System Code]) instrument.

This software allows the following functions to be carried out:

[(Insert system functions list; an example in the below)

  • analytical parameters control
  • data acquisition
  • data processing
  • production of reports/charts
  • data storage]

For Complete Template of CS Validation Plan for Lab. Instruments- Click on Read more, Subscribe and Download attachment   


DISASTER RECOVERY PROTOCOL FOR COMPUTER SYSTEM BACK UP RECOVERY

1.0 Objective:

objective of this document is to perform the Disaster Recovery using Veeam Agent Backup Software.

2.0 Scope:

This document is the test script for the recovery/restore of specified files/folders or entire system where backups were scheduled using Veeam Agent Backup software. This test script covers the technical procedure on how to perform the recovery or restore.

3.0 Test Scenarios

  1. Veeam Agent for Microsoft Windows as two types of restore options:
    1. Bare-metal restore: To restore the entire system image of computer or specific computer volumes.
    2. File level restore: Restore necessary data from backups to its original location or a new location.

4.0 Execution of the test scenarios

Select the test case to be executed here o Test Case 1 o Test Case 2 o Test Case 3

  1. Test Case 1 : Recovery of individual file(s) and/or Folder(s) only
  2. Test Case 2 : Restore complete volume to the same server hardware
  3. Test Case 3 : Restore the backup to a different hardware
  1. Test Case 1:  Recovery of individual file(s) and/or folder(s) 
    1. This section includes a description of the prerequisites required to successfully execute  the recovery procedure
  •  
  •  

Actual Result
  1.  

Define the file or folder to be deleted for this test.

This folder must already have been stored in backup

Enter the name of the file and or folder to delete here: (full path)

 

 

  •  
  1.  

Define the file to be modified for this test.

This file must already have been stored in backup

Enter the file name with original file date here:

 

  •  
  1.  

PC Name for recovery

Enter the PC name here:

 

  •  
  1.  

Identification of what to recover(folders/Files)

Enter what to recover here:

 

  •  
  1.  

Define recovery date

(Recovery date is the date from which data is to be recovered)

 

Enter Date:______________
  1.  

Delete folder(s) and file(s) defined in step 5.1.1-1

Confirm the deletion of File(s) and Folder(s) o Yes o No
  1.  

Modify the file defined in step 5.1.1-2 to generate a new date

Enter the new file date here:_____________

 

  1.  Recovery procedure test instructions by following below table and check Yes/No or NA depending on result at the time of testing. Evidence to be attached in the form of screenshots where ever possible.

 

Step

Test instruction

Successfully Completed ( If No or NA explain in comments)

5.1.2 -1

Login to Microsoft Windows Server  and navigate to Start MenuProgramsVeeamTools and select “File Level Restore”

Yes o

No o

NA o

5.1.2 -2

The File Level Restore window navigate to Restore point and select the date of restore point from 5.1.1-5 and click next

Yes o

No o

NA o

5.1.2 -3

On summary window click Open, Backup Browser window will open

Yes o

No o

NA o

5.1.2-4

Select the file(s) or  Folder(s) as defined in 5.1.1 -4

Yes o

No o

NA o

5.1.2-5

Right click on the selected file(s) or folder(s) to restore

Select Restore

Select overwrite

Wait for process to complete

Click OK on the dialogue

Yes o

No o

NA o