FDA Compliance

For years, many medical device manufacturers approached U.S. Food and Drug Administration (FDA) inspections through a familiar lens: Prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework. That approach was shaped by the…

With Hexagon Manufacturing Intelligence’s recent announcement of its inclusion in the NASCAR Competition Partner Program, details on the strategic partnership have emerged. By cementing this tie, the two companies can expand a professional relationship that will enable them to focus on precision…

As pharmaceutical manufacturers push toward lower detection limits, tighter impurity thresholds, and faster development cycles, elemental analysis has become a more critical part of quality and compliance.

Regulatory frameworks such as U.S. Pharmacopeia (USP) <232>, USP <…

In the larger organizations I worked for as a quality leader, supplier auditing was almost always calendar-driven. Sometimes supplier audits happened once a year; in other places, they might happen twice. I’d build the schedule to accommodate that, and the system would just run.

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FDA inspectors don’t just check your records. They bring their own thermometer.

And when their reading doesn’t match six months of logged data from the sensor on your cold room wall, the honest explanation is one nobody wants to say: The monitoring system was compliant; the…

Quality Digest recently spoke with David Isaacson, the executive director of portfolio marketing at Octave. Besides his work on marketing strategies, he also helps people manage, understand, and better control their operations with software solutions that protect industry assets and people while…