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 ...

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 ...

“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 ...

Good writing may be magical, but it’s not magic. It is the by-product of a rational series of decisions and actions. Fortunately for those of us struggling to write well, that process can be observed, ...