Subscribe The Website and Get the Access for All Documents Download for 1 Year
logo
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

 


1.0 INTRODUCTION

1.1 PURPOSE

The Purpose of this document is to summarize the Functional and Configuration Specification the LabSolutions Manager Version No. 1.122for “UV Spectrophotometer”. The system configuration detailed in this FCS document describes the configuration of the implementation of the system from a business, technical, and infrastructure perspective.  It includes the configuration items for the application hardware, operating system, software, interface, and data for the implementation of LabSolutions Manager Version No. 1.122 for UV Spectrophotometer.

1.2 SCOPE

The Scope of this Document is limited to Functional Configuration Specifications for the “LabSolutions Manager Version No. 1.122 for UV Spectrophotometer” installed at QC Department at XXXXXXXXXXXXXX.

1.3 REFERENCES

Reference Id

Document Number

Title

1.

USFDA 21 CFR Part 11

Electronic Records and Electronic Signatures.

2.

EudraLex Volume 4 Annex 11

EudraLex Volume 4 Annex 11: Computerized Systems

3.

GAMP 5

A risk-based approach to compliant GxP Computerized systems- Good Automated Manufacturing Practices

1.4 DEFINITIONS:

UV Spectrophotometer is a standalone and operated by LabSolutions Manager Version No. 1.122 Software. In addition, LabSolutions Software is standalone software provided by Shimadzu. The result is a UV Spectrophotometer System.

2.0 SYSTEM OVERVIEW

UV Spectrophotometer is a Standalone Software operated by LabSolutions Manager Version No. 1.122, which offers the qualitative and quantitative data of the entire scan. UV Spectrophotometer approach to data collection, analysis and reported provides a rare combination of simplicity and power. UV Spectrophotometer is a multifunctional, easy to use software for UV Spectrophotometer. Enable safe, reliable management of Data.

2.1 SYSTEM SCHEMATIC DIAGRAM

NA

3.0 FUNCTIONAL / DESIGN / CONFIGURATION SPECIFICATION:

The Functional & Design Specification for system for XXXXXXXXXXXXXXXX is defined below but no limited.

For Complete Protocol Click on read more and download


1.0 GENERAL

This document is prepared based on the assessment for “LabSolutions Manager Version No. 1.122for “UV Spectrophotometer” IRA is a collection of GxP assessment, Software hardware categorization and system impact assessment.

1.1 PURPOSE

The Purpose of this IRA document is to identify and the document that the “LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer”is determinate the IRA criteria.

1.2 OBJECTIVE

The objective of this document is to identify the Initial Risk Assessment of “LabSolutions Manager Version No. 1.122for “UV Spectrophotometer”. The assessment should be based on understanding of business processes and business risk assessments, user requirements, regulatory requirements, and known functional areas.

This risk assessment is likely to focus on important risks to GxP and to the business process, rather than detailed functions and technical aspects. The process owner and the quality unit, typically, are involved at this stage in addition to the input of appropriate SMEs

1.3 SCOPE

The Scope of this Initial Risk Assessment is only applicable for “LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer”installed at QC Department at XXXXXXXXXXXXXXX.

1.4 REFERENCES

The IRA Assessment Documents is consistent with the following references

Sr. No.

Document Description

Document No.

1.

GAMP-5, A Risk-Based approach to GxP Compliant Laboratory Computerized Systems 2nd Edition 2012

NA

2.

GAMP Good Practice Guide – A Risk-Based Approach to testing of GxP System, 2nd Edition, 2012

NA

3.

Validation Plan Protocol For UV Spectrophotometer

 

 

 

 

 

 

2..0 SYSTEM IMPACT ASSESSMENT

Important pre-requisites for this assessment are:

  • a clear understanding of the business process

  • a defined boundary around the business process

  • the role of the Control system in supporting the business process

  • sufficiently defined requirements (development of requirements may be iterative and influenced by the risk assessment)

​For complete Protocol click on readmore and download


1.0 INTRODUCTION

1.1 PURPOSE

The Purpose of this Validation Plan is to define the methodology and validation approach to validate the “LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer”. It also provides a list of documentation to be prepared during System Validation Lifecycle and defines the testing strategy

1.2 SCOPE

The Scope of this Validation Plan is Applicable for ““LabSolutions Manager Version No. 1.122 for UV Spectrophotometer” installed at QC Department at XXXXXXXXXXXXXXXX.

1.3 REFERENCES

Reference Id

Document Number

Title

1.

USFDA 21 CFR Part 11

Electronic Records and Electronic Signatures.

2.

EudraLex Volume 4 Annex 11

EudraLex Volume 4 Annex 11: Computerized Systems

3.

GAMP 5

A risk-based approach to compliant GxP Computerized systems- Good Automated Manufacturing Practices

1.4 ACRONYMS

Acronym

Definition

CSV

Computer System Validation

FCS

Functional Configuration Specification

FDA

Food and Drug Administration

GAMP

Good Automated Manufacturing Practice

GxP

Good Laboratory/Manufacturing Practices

IQ

Installation Qualification

OPQ

Operation and Performance Qualification

IT

Information Technology

SOP

Standard Operating Procedure

NA

Not Applicable

1.5 DEFINITIONS:

UV Spectrophotometer is a standalone and operated by LabSolutions Manager Version No. 1.122 Software. In addition, Lab Solutions Software is standalone software provided by Shimadzu. The result is a UV Spectrophotometer System.

2.0 SYSTEM OVERVIEW

UV Spectrophotometer is a standalone Software operated by LabSolutions Manager Version No. 1.122, which offers the qualitative and quantitative data of the entire scan. UV Spectrophotometer approach to data collection, analysis and reported provides a rare combination of simplicity and power. UV Spectrophotometer is multifunctional, easy to use software for UV Spectrophotometer. Enable safe, reliable management of Data.

3.0 VALIDATION APPROACH

This Validation Plan (VP) is developed to outline the requirements that shall demonstrate and document that the application is appropriate for regulatory requirements and applicable regulations, guidelines & accepted practices for validation. Below mentioned lifecycle phase will be used for validating the “LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer”. Follow system life cycle approach and respective documents should be developed as:

3.1 Planning Phase

3.1.1 Validation Plan

Validation Plan defines the scope and goals of a validation project. VP includes deliverables to be generated during the validation process and validation team for completing the project.

This plan specifies all validation requirements and deliverables for the validation effort inclusive of the different types of reports that will be produced in this project to cover the progress made, issues raised and the acceptance of the different phases of the validation plan (VP).

3.2 Specification Phase

3.2.1 Functional Configuration Specification:

This Document links IQ, OPQ Qualification, which tests functionality. The FCS will contain a testable description of various components and configurations. The FCS is a living document that must be prepared and maintained throughout the system validation and operational usage. It provides detailed descriptions of each of the final configurations for the “LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer”.

3.3 Qualification Phase:

3.3.1 Infrastructure Qualification:

NA

3.3.2 Installation Qualification:

Installation Qualification Protocol will be developed & executed to qualify the “LabSolutions Manager Version No. 1.122for “UV Spectrophotometer”. The IQ testing will be performed to ensure or to verify that the Control System components have been installed correctly as per the required specification. The tests to be performed during the IQ will be described in detail in the IQ document, which shall be pre-approved before execution and shall be post approved after execution.

3.3.3 Operational and Performance Qualification Protocol:

Operational and Performance Qualification (OPQ) Protocol shall be performed after the successful execution of IQ or after acceptable justification of any open discrepancy observed during IQ execution. OPQ testing will be operate to challenge the requirements defined in the user requirement specification for the“LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer” which ensures that the system operates as per the functional need. OPQ Protocol shall be pre-approved before execution and shall be Post approved after the execution.

Addendum to OPQ Protocol shall be prepared and executed in case some additional testing is required.

For Complete Protocol click on readmore and download


1.0 INTRODUCTION

1.1 PURPOSE

The Purpose of this Installation Qualification to establish the documented evidence that LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer (Inst. ID XXXXXXXXXXX)” installed properly. This protocol defines the tests to characterize the operation of the system and field verifications that confirm the system install according to the applicable manufacturer’s recommendations and user requirements.

Successful completion of this protocol provides assurance that the LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer (Inst. ID XXXXXXXXXX)” installed properly.

1.2 SCOPE

The Scope of this Document includes LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer (Inst. ID XXXXXXXXX)” which is installed in QC Instrument Lab at XXXXXXXXXXXXXXX.

Click on Readmore to download the protocol 


1.0 INTRODUCTION

2.1 PURPOSE

The Purpose of this Operational Qualification to establish the documented evidence that LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer (Inst. ID XXXXXXXXX)” operates properly. This document defines the tests to characterize the operation of the system and field verifications that confirm the system operates according to the applicable manufacturer’s recommendations and user requirements.

Successful completion of this protocol provides assurance that the LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer” (Inst. ID XXXXXXXXXX) operates properly.

2.2 SCOPE

The Scope of this Document includes LabSolutions Manager Version No. 1.122 for “UV Spectrophotometer (Inst. ID XXXXXXXXX), which is installed Instrument Lab at XXXXXXXXXXXXXXXX.

To download complete protocol click on readmore