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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's ...
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 ...
Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape. Computer system validation (CSV), also known as software validation, is required by ...
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 ...
Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...
SALT LAKE CITY, Aug. 06, 2020 (GLOBE NEWSWIRE) -- MasterControl, a provider of software solutions that enable life sciences and other regulated companies to deliver life-changing products to more ...
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 ...
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