Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Software testing, verification and validation form the backbone of modern software quality assurance. These interrelated activities ensure that a software system accurately implements its intended ...

This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...

Even with technology changing faster than validation procedures can be rewritten, it still is possible to perform thorough product testing. With the ever-changing complexity of automotive electronics ...

Evaluation methods rely on assumptions about how validation data and the data one wants to predict, called test data, are related. Traditional methods assume that validation data and test data are ...