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FDA Computer Software Assurance

FDA Computer Software Assurance

The U.S. Food and Drug Administration has distributed a draft of updated recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or quality systems.

Product quality and patient safety are central to identifying and promoting successful manufacturing practices.  While these recommendations are simply that, recommendations, the FDA recognizes that the “advances in manufacturing technologies, including the adoption of automation, robotics, simulation, and other digital capabilities, have allowed manufacturers to reduce sources of error, optimize resources, and reduce patient risk.” The possibility of these technologies to enhance quality, and availability, and ensure patient safety, enables the FDA to foster further the use of these technologies across the medical device manufacturing industry and identify regulatory solutions to further enhance patient safety.

The Pragmatyxs team recommends that you review your company’s assurance policies and procedures and identify areas for improvement ahead of the finalization of this guidance document so changes that may come down are easily implemented.

Steps that companies can take now as part of the FDA guidance for Computer Software Assurance include:

  • Identify the intended use
  • Determine the risk
  • Determine the appropriate assurance activities
  • Establish appropriate records

Our team is ready to assist you if you need support setting up a framework for Computer Software Assurance within your labeling solution.