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# Computer Software Assurance Guidance
- URL: https://www.fdaweb.com/computer-software-assurance-guidance/
- Published: 2025-09-23T12:00:00.000Z
- Updated: 2026-09-14T15:22:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159917

FDA has published a guidance, *Computer Software Assurance for Production and Quality System Software*, with recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. The [document](ttps://www.fda.gov/media/188844/download) says it 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
- 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.

The guidance includes an Introduction, Background, Scope, Definitions, Computer Software Assurance, and four Examples.