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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Market opportunities lie in integrating modern technology and agile methodologies to enhance compliance with FDA regulations. Emphasis on cloud services, validation approaches, and maintaining data ...

The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and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

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

Dublin, Sept. 10, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The ...

Gerard Holzmann at Bell Labs, Software to detect bugs in networked computers; Charles Howell at Mitre, Benchmarks for software assurance; Charles Simonyi at Intentional Software, Programming tools to ...

DUBLIN--(BUSINESS WIRE)--The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The attendee will learn ...

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.

Recently U.S. Army Europe's 5th Signal Command and the USAREUR directorate of information management sent an information infrastructure assistance team, or I2AT, to Schweinfurt, Germany to lighten the ...

WIRRAL, England--(BUSINESS WIRE)--LDRA, a leader in automated software verification, traceability and standards compliance, today announced extended support for the RISC-V instruction set architecture ...