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ap499 replied to the topic What are Design Controls? in the forum Introduction to Design Controls 6 years, 10 months ago
According to FDA, design control makes us demonstrate compliance with codes and it has nine parts. These nine parts are Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, and Design History File. Each of these nine parts has their own documentation to go along with it. Each document includes the importance of the project and details related to it. The purpose of the design control is to allow the company to make sure and provide all necessary requirements before launching the product in the market.