By: Steve Gompertz, QRx Partner I have lost count of the number of Quality Management Systems (QMSs) I have audited, observed, refined, or repaired over 30+ years in the MedTech industry. Over time, certain patterns emerge. One of the most reliable indicators of the health of a QMS is the relationship between the company's Quality Manual and the way the system actually operates. So here is the question: How many pages is your Quality Manual? 1 - 5 Pages Lean. Quality understa

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...