Forced updates and “patch and pray” thinking are creating avoidable risk in life-critical systems. Vendor business models, ...

On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” ...

I'm looking for some good change control software that's web based and utilizes SQL server. I used one a couple of years ago and can't recall the name. Google didn't turn up much that looked ...

Most everyone knows networked multifunction printers can pose a dangerous weak link within an enterprise, but not everyone agrees on just how to secure them. Printer manufacturer Sharp upped the ante ...

At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission ...

The U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is ...

Pankaj Goel is the technology leader and cofounder of Opkey, an Agentic AI-powered ERP lifecycle optimization and assurance platform. Five years ago, Gartner released a seminal paper that introduced ...

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...