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Annex 11 - Computerised Systems

Date into Effect: Jun 12, 2025 GMP + GDP EMA Qualification & Validation Software

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FDA Computer Software Assurance Guidance

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.

Date into Effect: Feb 3, 2026 GMP + GDP US FDA Software Medical Devices

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