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 ...

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

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality ...