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GUIDANCE DOCUMENT

Computer Software Assurance for Production and Quality System Software Guidance for Industry and Food and Drug Administration Staff September 2025

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2022-D-0795
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0795.

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