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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 ...

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 ...

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

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The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and ...

Software engineering is the branch of computer science that deals with the design, development, testing, and maintenance of software applications. Software engineers apply engineering principles and ...

Dublin, Jan. 06, 2026 (GLOBE NEWSWIRE) -- The "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA - Modular Course for Practitioners (Jan 21st - Jan 26th, ...

Businesses that want the Enterprise Edition of Microsoft Corp.’s forthcoming Windows Vista operating system will have to sign up for its Software Assurance licensing program, the company announced ...