Standards
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…
ISO 9001:2026 is in its final development stage. The final draft international standard (FDIS) has been submitted for ballot, and publication is expected in September 2026. That gives certified organizations approximately three years to make the transition—with a deadline that currently points…
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…
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…
For more than 30 years I’ve audited management systems in manufacturing, automotive, laboratory, service, and nuclear environments. During that time I’ve watched internal auditing change shape several times. Paper checklists gave way to process-based auditing. Filing cabinets gave way to digital…
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…