Computer Software Assurance for Production and Quality Management System Software (FDA guidance)

FDA · Final

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Summary

FDA's risk-based approach to assuring software used in production and quality systems, favouring critical thinking and unscripted testing where risk is lower. Final since September 2025 and updated in February 2026 to align with the QMSR.

Dated events

1. 3 Feb 2026 Updated and retitled for QMS software Source for Updated and retitled for QMS software
2. 24 Sep 2025 Final guidance published Source for Final guidance published
3. 13 Sep 2022 Draft guidance published Source for Draft guidance published

Official source

Official text

Source: FDA. Public domain.