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

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

To test complex devices, test engineers must rely on the vector sets generated by verification engineers. Unfortunately, verification engineers—who work in a software simulation environment—often have ...