Prevalidation of computer systems regulating medical device manufacturing processes

When developing a computer system for regulating a medical device manufacturing process, it is advisable to incorporate validation criteria in the design and development of the system from the very beginning. Quality begins at the design stage and cannot be added at a later stage of system development. In this article, the author details the step-by-step process of software development that is recommended by the United States Food and Drug Administration (FDA) and utilized by the company in its development of a prevalidated sterilizer control system. By following FDA recommendations and using an external consultant to confirm validation, a prevalidated system can be supplied to the end-user. This provides the end-user with a number of significant benefits.