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Sets the criteria under which the FDA considers electronic records, electronic signatures and handwritten signatures executed to electronic records to be trustworthy, reliable and equivalent to paper records. Covers controls for closed and open systems, signature manifestations and record linking, and electronic signature components, controls and identification codes.
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This is an FDA guidance document titled "Computer Software Assurance for Production and Quality Management System Software," issued February 3, 2026. It provides recommendations for how medical device manufacturers should establish confidence that the computer software they use in production and quality management systems is fit for its intended purpose.
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