ABSTRACT
Design controls are needed to ensure products meet specified requirements, user needs, and are safe and effective for their intended use. The product development process must also address the purchasing, production, marketing, financial, and customer expectations required for the product in addition to all those things that the product must do to be safe and effective for its application. The design and development process is often depicted as consisting of a logical sequence of phases or stages. Design verification product builds and testing must be performed using processes that are representative of the proposed manufacturing process using calibrated equipment and validated test methods, as applicable. Validation typically follows successful verification and is performed using initial production lots under defined operating conditions in accordance with the design and development plan. Validation activities should involve test systems and environments representative of true end-use conditions.
