FDA Compliance
A CAPA investigator opens an AI-enabled quality management system and asks for potential root causes. The system produces several plausible explanations, summarizes similar historical events, and recommends corrective actions. The investigator reviews the suggestions, selects one, and closes the…
The U.S. Food and Drug Administration’s April 2, 2026, warning letter to Purolea Cosmetics Lab is making the rounds, mostly under some version of “FDA cracks down on AI in manufacturing.”
That’s the wrong way to read this. If you build medical devices, treating this issue as an AI…
MIT launched a new initiative—titled Science Is Curiosity on a Mission—to make the case for the long-horizon, curiosity-driven science that has powered generations of American innovation. Through stories of scientists pursuing open-ended questions, the project highlights how fundamental…
Here’s a scenario that should make any quality leader in pharma or medical devices uncomfortable: A software team building a diagnostic support tool uses an AI coding assistant to generate a data-processing module. The module looks correct, passes validation testing, and ships. Eighteen months…
Josh Santo, senior director of industry strategy and solutions at EASE, spoke more about the findings behind a full layered process audit (LPA) benchmark report of plant-floor quality audits. Data covered 2.3 million process checks spanning more than 2,200 manufacturing sites. The report not…
The food manufacturing industry has spent the last two years trying to figure out where AI fits: Vision inspection systems? Predictive maintenance? Yield optimization? Contamination detection? The applications are real, but they’re expensive, technically complex, and often require significant…