I’ve seen this story play out more times than I can count. A product starts in R&D with a lot of excitement and momentum. Smart scientists and engineers are focused on innovation, performance, and getting something new into the world. Quality gets involved later, sometimes much later, often when timelines are tight and decisions feel locked in. That gap between R&D and Quality is where many companies unknowingly create risk. Not because anyone is doing a bad job, but because

Every November, somewhere between planning holiday travel, juggling year-end projects, and wondering if I made enough applesauce, I find myself slowing down just long enough to reflect on the year. And every time I do, I come back to the same feeling:deep gratitude for the work I get to do and the people I get to do it with. Quality isn’t flashy. It isn’t loud.It certainly isn’t the first department mentioned in a press release. But it is the backbone of trust — trust in prod

Outsourcing has become the backbone of modern pharmaceutical and medical device operations. Sponsors increasingly rely on Contract Development and Manufacturing Organizations (CDMOs) for speed, expertise, and scalability. But as outsourcing continues to expand, so does regulatory oversight. The FDA and EMA have made it clear: while CDMOs perform the work, sponsors remain ultimately responsible for the quality and compliance of their products. Outsourced does not mean out of s

When people think about building a compliant quality system, their minds often go straight to procedures, documentation, and audits....