If you've ever ended a day wondering why you were buried in documentation instead of driving improvement, you're not alone. I lived that reality for years. As a Quality Manager in life sciences, I spent countless hours reviewing documents repeatedly for compliance. At one point, I started measuring the quality of CAPA records coming across my desk. The results were sobering: only 40% passed review on the first attempt . That meant 60% of records required rework, additional ro

Congratulations - You just closed the acquisition and convened the all-hands meeting to celebrate! Now comes the hard part: assessing the newly acquired company’s quality system for compliance gaps and prepare to integrate with your own. For many life science companies, post-acquisition quality integration is one of the most underestimated challenges. Differences in documentation standards, procedure structures, and record quality can quietly stall integration plans for month

Your company is preparing for an external audit. As you start reviewing your key records that you expect the auditor to review, you find...

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...