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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

PICATINNY ARSENAL, N.J. -- The Fire Control Systems & Technology Directorate (FCSTD) at Picatinny Arsenal has been selected for a prestigious award that recognizes outstanding achievements in ...

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 ...

BURLINGTON, Mass., Feb. 03, 2026 (GLOBE NEWSWIRE) -- ETQ, part of Hexagon, today announced that it has been positioned by Gartner as a Leader in the Magic Quadrant for Quality Management System ...

The present publication provides for the first time information and guidance for defining and implementing quality assurance programmes covering the entire life-cycle of software important to safety.

Siemens announced it has been recognized as a Leader in the Gartner Magic Quadrant for Quality Management System Software1.