https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software
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 “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality systems, and identifies where
additional rigor may be appropriate; and
• Describes 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 quality system obligations, including requirements in 21 CFR Part 820 (hereafter referred to as “Part
820”).2
1 This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Inspections and Investigations (OII).
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