Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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

ZenQMS and Sware provide Life Sciences organizations with a modern, risk-based approach to validating ZenQMS implementations and ongoing software releases ARDMORE, PA, UNITED STATES, July 22, 2026 ...

The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production.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 "Computer System Validation (CSV) Training Course (Jan 27th - Jan 29th, 2026)" training has been added to ResearchAndMarkets.com's offering. A course designed to completely immerse you in computer ...

"Risk should be the compass, not the paperwork," said Sindhuri Korrapati, a senior software quality supervisor. It's a striking statement in a field long defined by binders, screenshots, and scripted ...

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

Validify has introduced an AI-powered validation platform designed to modernize computer software validation for pharmaceutical, biotechnology and ...

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 ...