V- Model Validation Concept in Pharmaceuticals

V- model means Verification and Validation model. It is a widely accepted reference model for computer system validation and was introduced by International Society of Pharmaceutical Engineers (ISPE) in 1994 in the first edition of their Good Automated Manufacturing Practices guideline, (gAMP).

It is called the V-model because of it’s characteristic “V” shape. The left arm of the “V” represents the planning / specification phases such as User Requirements Specification, Functional Specification, Detailed Design, and the right arm of the “V” represents the execution-validation phases such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) and both the arms converge at the Build and Unit Testing phases at the V-Point.

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The V-model provides a logical sequence that helps to organize the complex activities of defining a project scope, executing it, and qualifying it.

The V model provides an excellent basis for design control and tracking design changes through the proceeding of the project.