The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...

The emerging Department of Government Efficiency (DOGE) has sparked discussions about cutting spending and reducing the size of government to improve efficiency. But the fundamental problem hampering ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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

With QMS/SCADA integration, operators can perform inspections within their SCADA interface, with automatic logging and immediate alerts when quality drift occurs. Unified platforms reduce licensing ...

POMONA, Calif.--(BUSINESS WIRE)--PSC Software ® is excited to provide our ACE ® electronic Quality Management System (eQMS) customers with four powerful enhancements. Current ACE users never have to ...

The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production. FDA said the draft ...

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 ...