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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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

2 Day Online Training Course - Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities (Oct 16th - Oct 17th, 2025 ...

DUBLIN--(BUSINESS WIRE)--The "Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities (Oct 16th - Oct 17th, 2025)" training has been added to ...
Mena FN

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 ...

(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities lie in integrating modern technology and agile methodologies to enhance compliance with FDA regulations. Emphasis on cloud services, validation ...