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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Manufacturing Inspection Software: Digital Platforms Vs Manual Data Entry

Burlington, Massachusetts / Syndication Cloud / March 4, 2026 / Alpha Software Key Takeaways Real-time manufacturing ...
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 ...
JD Supra

FDA finalizes computer software assurance guidance for production and quality system software

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
Automation World

Embedding Quality Management at the SCADA/MES Layer

With QMS/SCADA integration, operators can perform inspections within their SCADA interface, with automatic logging and immediate alerts when quality drift occurs. Unified platforms reduce licensing ...