FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice. FDA issued the guidance document Process Validation: General Principles ...

Improving efficiency is complex and requires a multimodal approach. Health information systems, patient feedback, and multidisciplinary teams are components that can improve clinical processes.

“High stakes tests” encompass any tests used to make significant decisions about a person’s care and are intimately tied to an individual’s medical treatment, social perception by others, and often ...