Computer Software Assurance for Production and Quality System Software Draft Guidance for Industry and Food and Drug Administration Staff September 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2022-D-0795
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

FDA is issuing this draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the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 This draft guidance is intended to:

• Describe "computer software assurance" as a risk-based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate; and
• Describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR part 820 (Part 820).

When final, this guidance will supplement FDA's guidance, "General Principles of Software Validation" ("Software Validation guidance") except this guidance will supersede Section 6 ("Validation of Automated Process Equipment and Quality System Software") of the Software Validation guidance.

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