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Quality Management

CSA for Production and Quality System Software

Computer Software Assurance for Production and Quality System Software

The FDA has announced the draft guidance entitled Computer Software Assurance for Production and Quality System Software.

This draft guidance provides recommendations on computer software assurance for computers and automated data processing systems which are used as part of medical device production or quality system.

FDA believes that these recommendations will have the following benefits: 

  • They will help raise the adoption and use of innovative technologies that promote patient access to high-quality medical devices
  • They will help manufacturers to keep pace with the dynamic, rapidly changing technology landscape, while promoting compliance with laws and regulations implemented by FDA.

The CSA approach provides manufacturers flexibility, efficiency and agility by allowing manufacturers to leverage principles such as:

  • Risk-based testing
  • Unscripted testing
  • Continuous performance monitoring
  • Data monitoring
  • Validation activities performed by other entities

This draft guidance is intended to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
  • 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)


This guidance is not intended to provide a complete description of all software validation principles. FDA has previously outlined principles for software validation, including managing changes as part of the software lifecycle, in FDA’s Software Validation guidance.