Software Validation of Lab. Instrument

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]

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