Even when change is good, most of us would rather run the other way when we see it coming. This is simply human nature, especially when a system seems to be working satisfactorily. But the reality is ...

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 ...

“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 ...

A cognitive assessment strategy that is not limited to examining a set of summary test scores may be more helpful for early detection of emergent illness such as Alzheimer’s disease (AD) and may ...