FDA Compliance
Most environmental monitoring programs I see are run in a clean, cold, empty plant. Sanitation finishes at 4 a.m., the swabs go down at 5, the results come back negative, and the report gets filed. The program is compliant. It’s also, in the way that matters, telling you almost nothing.
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Most discussions about generative AI in life sciences start with the technology. Quality professionals should start somewhere else—with the record.
Our job has never been to produce documents. It has been to produce evidence that decisions were made correctly, by the right people…
When hospitals treat device downtime as isolated, one-off incidents, they miss a critical opportunity to improve system reliability, manage long-term costs, and safeguard patient care. Downtime patterns often reveal far more than a single equipment failure; they point to the underlying condition…
A longtime raw-material supplier exits the market, and a manufacturer needs a replacement quickly. The new supplier completes a questionnaire, receives approval, and begins shipping. Months later, delivery slips and defects increase. A broad audit produces a passing score, but the problems…
Manufacturing Day fell on Oct. 2 this year. Manufacturers opened their doors and showed the public what modern manufacturing looks like, and, hopefully, built some interest in manufacturing careers.
Visitors saw robots, sensors, software, and connected production systems. What…
Recent cyberattacks on U.S. water and wastewater systems (WWS) are highlighting the escalating threat to our nation’s critical infrastructure and the practical challenges of securing it.
These incidents underscore an important challenge: The connectivity that utilities depend upon…