The exact state of computer software validation (CSV) can be tricky to pin down. While industry insiders can call it slow to change, attempting to sort through various complex procedures, approaches, ...

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 ...

The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs.

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

A course designed to completely immerse you in computer system validation. This course delivers comprehension of the regulations impacting your systems and hands-on practice writing validation ...

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 ...

The “Computer System Validation Boot Camp” seminar has been added to worldcomplianceseminars.com offering. RALEIGH, N.C., July 13, 2021 (GLOBE NEWSWIRE) -- World Compliance Seminars (WCS), a leader in ...

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction. JohanSwanepoel - Stock.Adobe.com Editor’s Note: This article ...