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 ...

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

The era that spawned Enron, Tyco and Adelphia has turned, and on its heels is a new trend to get back to the basics of ethical business practices. In my role as a process analyst, I’ve found that the ...

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 ...