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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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

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 ...
PharmiWeb

3 Day Virtual Computer System Validation (CSV) Training Course | Streamlined Validation with a Focus on Risk-Based Approaches (Sept 23rd - Sept 25th, 2025) - ResearchAndMarkets.com

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 ...
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 ...
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 ...