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

This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...
Yahoo Finance

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

CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...
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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
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.