Women in Validation: In Case You Missed It

One of my annual “must attend” events is the Institute of Validation Technology (IVT) Computer Systems Validation Annual Validation Week in October.  This is an excellent event to get the latest and greatest thinking on validation topics and industry guidance.  An official from the U.S. FDA attended the event and providing key information on the […]

Can Microsoft Azure Be Validated?

The text book definition of computer systems validation (paraphrased) is “documented evidence that a system performs according to its intended use”.  The FDA uses the definition “…Validation is a process of demonstrating, through documented evidence, that <software applications> will consistently produce the results that meets predetermined specifications and quality attributes.” Using the FDA’s definition, one […]