By Steve Gompertz, QRx Partners When the FDA released the final Computer Software Assurance for Production and Quality System Software guidance, many in the industry expected only minor edits from the 2022 draft. They were wrong. The final version goes well beyond clarifying language. It reflects how dramatically manufacturing and quality systems have evolved, and how tightly FDA now aligns with ISO 13485 and modern digital infrastructure. A New World Under the QMSR How ofte

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...