FDA guidance on Computer Software Assurance for production and quality management system software

10th February 2026

Summary: This FDA guidance sets out the agency’s expectations for Computer Software Assurance (CSA) when software is used in production or as part of a quality management system (QMS) for FDA-regulated products. It encourages a risk-based, least-burdensome approach, focusing assurance activities on software features that could impact patient safety, product quality or data integrity, rather than applying the same level of validation to all functions. The guidance explains how manufacturers can leverage supplier documentation, automated testing and unscripted testing where appropriate, and move away from excessive documentation that does not add value. CSA is positioned as a way to support innovation, digitalisation and modern manufacturing practices while maintaining compliance with 21 CFR Part 820 and other applicable requirements.

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-management-system-software

Back to Recent News