After many years of navigating the difficult task of properly validating quality system and production software tools, FDA released the “Computer Software Assurance for
Production and Quality Management System Software Guidance for Industry and Food and Drug Administration Staff” on February 3, 2026. While this release may have not been noticed by many, it is very significant, in our opinion, because it solidifies the FDA intent to expect (and accept) risk based approaches to validating these tools rather than a “one size fits all” inefficient and rote approach. The manufacturer is encouraged to analyze the most effective approach, holistically across all software tools.

You can download the guidance here:  2026-guidance-computer-software-assurance-production-quality-system