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 ...
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 ...
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 ...
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 ...
The Computer Software Assurance (CSA) industry is experiencing rapid digital transformation as organizations prioritize robust software validation and compliance. Growing regulatory mandates and the ...
DUBLIN--(BUSINESS WIRE)--The "The FDA Recently Released a New Draft Guidance Related to Part 11" webinar has been added to ResearchAndMarkets.com's offering.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 ...