Burlington, Massachusetts / Syndication Cloud / March 4, 2026 / Alpha Software Key Takeaways Real-time manufacturing ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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

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 ...

Quality management systems (QMS) have been in place since the beginning of the Industrial Revolution. They were used to manage and curtail defects in products and eventually evolved to become a set of ...

Transition from reactive quality assurance to proactive quality engineering by embedding shared responsibility throughout the ...

Poor software quality cost the U.S. economy an estimated $2.41 trillion annually in 2022, according to the Consortium for ...