By: Steve Gompertz, QRx Partner It might sound like failure to say that I earned a degree in Mechanical Engineering and then never worked...

by: Steve Gompertz, QRx Partner I had an interesting discussion recently during a client audit on something I see often in CAPA...

By: Steve Gompertz, QRx Partner If you work in Medical Devices, you should already know that the FDA’s regulation 21 CFR Part 820 has...

By Steve Gompertz, QRx Partner As a consulting firm we get courted frequently by eQMS vendors who hope we will introduce our clients to...