Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Soroosh Khodami discusses why we aren't ready ...

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” ...

On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled ...

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 ...

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 ...

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 ...

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 ...