Computer Software Assurance for Production and Quality System Software

SEPT 2025: FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.

This guidance describes a risk-based approach to establish confidence in the automation used for production or quality systems, identify where additional rigor may be appropriate, and various methods and testing activities that may be applied to establish computer software assurance.

FDA’s goal is to help manufacturers produce high quality medical devices while complying with the Quality System regulation, 21 CFR Part 820. This guidance supplements FDA’s guidance, “General Principles of Software Validation” except this guidance supersedes Section 6 (“Validation of Automated Process Equipment and Quality System Software”) of the “General Principles of Software Validation” guidance.