ABSTRACT
A good quality assurance professional must know the advantages and disadvantages of validation, qualification and specification testing. This chapter discusses the roles of these three quality assurance tools in medical product development and manufacturing. Device design validation studies must be completed before new products are marketed. Validation studies for product manufacturing processes must also be completed before new products are marketed, but these studies should occur before new products are manufactured for human use. A good quality assurance professional must know the advantages and disadvantages of validation, qualification and specification testing in order to support cost- and time-efficient operations as well as product quality claims. The testing of products, processes or methods to demonstrate their compliance with predetermined specifications has been a fundamental requirement of Good Manufacturing Practices and continues to be a requirement of the Quality System Regulations. Validation studies and/or the use of validated processes impact everyone in the product development, manufacturing and testing areas.
