Why measuring before you deploy AI determines whether ROI can be proven Artificial intelligence (AI) is often positioned as the answer to slow, manual, or tedious processes. And in many cases, it can be. But across many organizations exploring AI, one issue consistently undermines the ability to assess return on investment (ROI): Baseline data does not exist. Instead of quantified evidence, teams rely on a general sense that a process is inefficient: “ This process takes too

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...