On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...

Deciding on Microsoft's Software Assurance (SA) option isn't getting any easier, to hear an independent licensing expert tell it. Rob Horwitz, research chair at Directions on Microsoft, presented the ...

I had an interesting conversation recently about the after-effects of Heartbleed and the challenges facing static analysis with Barton Miller, the chief scientist of the Software Assurance Marketplace ...

AI, Assurance, and GxP AI's arrival in regulated operations has made CSA even more critical. Whereas classic CSV focused on software logic and static requirements, AI demands validation that considers ...

Several major power companies have launched a software assurance database that will serve as a software bill of materials (SBOM) repository for the power industry. Part of a long-sought solution to ...

If you are like me you hate being asked to purchase insurance against a product failing. I regularly refuse insurance coverage for computers and electronics. It always seems underhanded for the ...