Nearly every organization now reports “using AI.” ChatGPT licenses are everywhere. Copilot is embedded in Office. Teams are experimenting daily. But here’s the uncomfortable truth: Most organizations’ performance haven’t fundamentally changed, including Quality Management Systems. Complaint backlogs still exist. CAPA cycles are still long. Audit prep is still stressful. Independent reviews still consume senior reviewer time.  Audit findings still occur. Why? Because many organizations are...

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 months — or even lead...

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