KXAN

InstantGMP Modernizes Software Validation with FDA Computer Software Assurance-Aligned Approach

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.
BioWorld

Ambiguity a sticking point for industry in FDA’s computer software assurance draft

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
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

CSA in Practice Training Webinar: How to Build Defensible Evidence the FDA Actually Wants to See (ONLINE EVENT)

Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See (Jan 13, 2026)" training has been added to ResearchAndMarkets.com's ...
Yahoo Finance

Digital Validation and Cloud Assurance Modular Course for Practitioners: Validating SaaS, PaaS and Automated Pipelines under CSA (Jan 21st - Jan 26th, 2026)

Dublin, Jan. 06, 2026 (GLOBE NEWSWIRE) -- The "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA - Modular Course for Practitioners (Jan 21st - Jan 26th, ...