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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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

Implementing CSA For Gxp Systems: Transition, Documentation, And Post-Transition Challenges And Opportunities - 2 Day Online Training, Oct 16Th - Oct 17Th, 2025

(MENAFN- GlobeNewsWire - Nasdaq) The main market opportunities lie in adapting FDA-regulated computer system validation methods to align with GAMP®5 Second Edition and CSA, embracing innovative ...
Yahoo Finance

1 Day Virtual Course: Emerging FDA Trends in Computer System Validation (CSV) Compliance and Enforcement

Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Emerging FDA Trends in Computer System Validation (CSV) Compliance and Enforcement (April 9, 2026)" training has been added to ResearchAndMarkets.com's ...
PharmTech

The Punctuated Evolution of Computer Software Validation

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation. The exact state of computer software validation (CSV) can be tricky to ...