Guidance for Computer Software Assurance for Devices
FDA has released a draft guidance entitled “Computer Software Assurance for Production and Quality System Software.” The document describes a risk-based approach for “computer software assurance” to establish confidence in the automation used for production or quality systems, and to identify where more stringent controls may be appropriate. It also 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 21 CFR part 820,” the agency says.
The guidance is part of FDA’s vision of helping industry raise manufacturing quality levels. “Recommending best practices should promote product quality and patient safety, and correlate to higher-quality outcomes,” the agency says. “In recent years, 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. FDA recognizes the potential for these technologies to provide significant benefits for enhancing the quality, availability, and safety of medical devices, and has undertaken several efforts to help foster the adoption and use of such technologies.”
One such effort is seen in FDA’s work with stakeholders under the Medical Device Innovation Consortium, which encourages site visits to device manufacturers, and benchmarking efforts with other industries to stay on top of the latest technologies and to better understand stakeholders’ challenges and opportunities for further advancement, according to the agency. “As part of these ongoing efforts, medical device manufacturers have expressed a desire for greater clarity regarding the agency’s expectations for software validation for computers and automated data processing systems used as part of production or the quality system,” FDA says in explaining why the guidance was developed. “Given the rapidly changing nature of software, manufacturers have also expressed a desire for a more iterative, agile approach for validation of computer software used as part of production or the quality system.”
Instead of focusing on traditional software validation, FDA says it now believes that applying a risk-based approach to computer software used as part of production or the quality system would better focus manufacturers’ assurance activities to help ensure product quality while helping to fulfill the agency’s validation requirements. Under this approach, FDA says it is providing recommendations on computer software assurance for such systems, which should “help foster the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers to keep pace with the dynamic, rapidly changing technology landscape…”