Software quality is a strange animal — nobody really cares about it until it’s missing. But as soon as there’s an incident that can be traced back to a software malfunction, it suddenly becomes ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Software quality is a multifaceted concept that encompasses not only the functional correctness of software systems but also the structural soundness that underpins long‐term maintainability, ...

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 ...

Fabasoft, a leading European cloud vendor for document and business process management, has been positioned as a Challenger with its Fabasoft Approve product by Gartner® in its first Magic Quadrant™ ...

CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...

The emerging Department of Government Efficiency (DOGE) has sparked discussions about cutting spending and reducing the size of government to improve efficiency. But the fundamental problem hampering ...

Shares of Quality Systems (NAS: QSII) hit a 52-week low on Wednesday. Let's take a look at how it got there and see whether cloudy skies are still in the forecast. You'd think that both technological ...