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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Dublin, Aug. 16, 2021 (GLOBE NEWSWIRE) -- The "Computer System Validation Boot Camp" training has been added to ResearchAndMarkets.com's offering. A course designed to completely immerse you in ...

Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...

Computer system validation, popularly known as CSV is the process of procuring documented evidence that ensures the consistent performance of a computerised system as required by the operational ...

Regulation and the pharmaceutical sector are intrinsically linked. Indeed, it’s no exaggeration to state that the global pharmaceutical sector is one of the most heavily regulated industries in the ...

The computer vision leader offers controlled release cloud-based software to speed up innovation for life-enhancing drugs and medical devices PALO ALTO, Calif., May 2, 2023 /PRNewswire/ -- Landing AI, ...

This webinar describes efficient techniques for performing COTS validation. The 10-step risk-based approach to COTS software validation makes documentation more manageable and understandable. Learn ...

With car companies adding more cameras, digital display screens, active safety systems and other technology to their vehicles with each passing year, they are starting to rely more and more on ...

General Dynamics Itronix's GDAssure Solution Validation and Installation Certification Program evaluates and certifies that a customer’s rugged computer, software and peripherals operate as they are ...