The Concept of a Validation Plan

Abstract

A validation plan is developed to show beyond any doubt that a computer program, software system, or hardware configuration will consistently perform as intended within pre-established operational limits. This concept, while stating fact, is defensible with the implementation of a comprehensive, well-documented validation plan. It has been widely stated and published by P. J. Motise¹ of the Food and Drug Administration that there are five main areas of system validation:

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Defining the task to be performed and matching the task to a computer system.

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Identifying the system's operational limits and incorporating those limits in a standard operating procedure.

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Testing of the system.

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Documentation of the system.

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Establishing a mechanism to detect change and precipitate revalidation.

This paper will identify an approach the author has implemented at Revlon Health Care R&D to satisfy FDA validation requirements.