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

Analyst firm publishes overview of providers of quality management software ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 ...

Optimation has been certified in ISO 9001 since 1996—one of the first service companies to do so. We were also among the early adopters—since 2001—of the best practices established by the Control ...