Software Assurance Guidance Supplement

FDA has published a guidance, Computer Software Assurance for Production and Quality Management System Software, to supplement an earlier guidance on General Principles of Software Validation. The new document contains recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality management system.

The 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 regulatory requirements in specified sections that incorporate by reference the 2016 edition of ISO 13485.