Validation Overview

What is Validation?

The short textbook definition of validation is: "Proof of Specified Performance". It follows that a validation process requires; Specification, Performance and Means of Proof.

Who is responsible for validation?

The company using the process or system to be validated. There is no such thing as a validated system which can be delivered into a user company without any additional validation work being required. The reason for this is that the most important part of the validation process is one of determining and proving the suitability of a purchased system for its designated function and, going forward, its continued appropriate use by the purchaser. The ease of being able to carry out this process will define the validatability of the system. This will depend on the quality of the supplier's supporting documentation and procedures.

How is it done?

The first step in the validation process is the production of a validation plan where a company sets out the intended validation procedures for a given process or system. This plan should describe the validation steps to be taken and define successful outcomes at each stage of the process. The most common structure of the validation process is based on the performance of the following five Qualification steps:

	Specification Qualification.
	Construction Qualification.
	Installation Qualification.
	Operational Qualification.
	Performance Qualification.