AI promises game-changing efficiency, consistency, and scalability. But here’s the hard truth: those benefits rarely appear automatically....

The FDA was here. They left behind a 483 and a mountain of work. You’ve spent the weekend reading the findings, line by painful line. Now...

When some companies initially consider AI tools for their quality system, they often think of them like any other software: install it,...

The FDA arrives at your facility for an unannounced inspection.  The first records the investigator requests is all of your complaints...