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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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

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 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 ...

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 ...

Interview: As software grows more distributed and AI accelerates code creation, Umasankar Mukkara explains why resilience testing is becoming central to modern software quality.