Risk is a lens, not a leash. Once teams see what truly threatens patients and processes, the busywork falls away, and quality ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and ...

SCHWEINFURT, Germany (Dec. 5, 2007) -- Over the past several years the U.S. Army has invested billions of dollars in computer software, hardware and equipment to keep up with the world's ever-changing ...

The Computer Software Assurance (CSA) industry is experiencing rapid digital transformation as organizations prioritize robust software validation and compliance. Growing regulatory mandates and the ...

In modern integrated computer systems, assurance activities such as assessments, tests, and audits are increasingly difficult to perform in multi-party environments. But there are a few key tactics ...

DUBLIN--(BUSINESS WIRE)--The "The FDA Recently Released a New Draft Guidance Related to Part 11" webinar has been added to ResearchAndMarkets.com's offering. As part of the Case for Quality program US ...

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 ...