FDA Compliance
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…
Many leaderships teams staring down the barrel of organizational transformation face a similar dilemma: How do you take a leap into the unknown when there are no clear data, no well-trodden path to follow, and no assurance of success? What if the change you’re considering is uncharted territory…
Our video producer Chris Smith almost watched the Artemis II launch in person. He drove to Kennedy Space Center with all his fancy gear, along the way got stuck in the snow twice—in Texas, of all places—and then NASA scrubbed the launch and rolled the rocket back for repairs. So Chris drove back…
Corrective and preventive action (CAPA) is the backbone of any quality management system. It’s where problems get solved, risks get reduced, and processes become more robust. Yet in many organizations, CAPA has become little more than a documentation exercise.
Forms get filled.…