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CPC Comments on FDA’s Draft Guidance “Computer Software Assurance for Production and Quality System Software”

On November 14, 2022, the CPC submitted a comment letter to FDA regarding the Agency’s draft guidance, “Computer Software Assurance for Production and Quality System Software”. The CPC greatly appreciates FDA’s efforts to provide this draft guidance, which helps to establish Agency expectations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. The CPC’s comments focus on applicability of the draft guidance to pharmaceutical- and drug-primary mode of action combination product production and quality system software.