JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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

Worried About Computer Software Assurance? Relax, You're Probably Already Doing It

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 ...
Yahoo Finance

2 Day Virtual Computer System Validation (CSV) Training Course: COTS, SaaS, IaaS, and PaaS Models with Best Practices for Validation, 21 CFR Part 11, and Data Integrity (Nov ...

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV) (Nov 4th - Nov 6th, 2025)" training has been added to ResearchAndMarkets.com's offering. Advancements in technology have ...

Computer System Validation (CSV) Training Course: Regulations Impacting Your Systems and Hands-on Practice Writing Validation Documents (Jan 27th - Jan 29th, 2026 & On-Demand)

The main market opportunities include training on modern technologies for computer system validation, compliance with evolving FDA regulations, and risk-based approaches to validation using CSA and ...