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 management system.
This guidance:
· Describes “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality management 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 management
system obligations, including requirements in 21 CFR Part 820, which includes incorporations by reference of the 2016 edition of ISO 134852
The update reinforces a – to software assurance, clarifies expectations for validation and testing activities, and provides important direction on supplier leverage, cloud-based systems, and electronic records.
For manufacturers relying on software in production or QMS processes, understanding these updates is essential to remain compliant while applying proportionate, risk-based validation activities.