Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...

The life sciences industry operates under uniquely stringent regulatory requirements where technology systems must not only ...

Polestar’s sweeping recall of its Polestar 2 sedans in the United States has become a stress test for how quickly the ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

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 ...

In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...

In today’s highly regulated industries, from pharmaceuticals to medical devices and biotech, maintaining data integrity and ensuring compliance with regulatory standards is non-negotiable. This is ...

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 ...

Volvo is upgrading the central computer on all 2025 EX90s for free. The company has spent over a year trying to squash software bugs in the EX90, but owners are still reporting serious issues and ...

The Zacks Computer Software industry participants are well-positioned to benefit from the accelerated digital transformation drive globally. The shift to cloud and the rise of SaaS ...