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Michaela Flux,2 Lucia Hernandez Pena , 2,3 Molina Pakistan,1 Kathy SEM,1
Yael Pay,2 Rita Plate,2 Bromide Coppola,2
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Development and validation refer to the process of creating and rigorously testing a system, product, or method to ensure it meets required specifications and operates effectively.
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Entities or individuals involved in the development of regulated products, such as pharmaceuticals, medical devices, or software, are typically required to file documentation of development and validation.
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To fill out the development and validation documents, gather all necessary data regarding the development process, methodologies used, results of validation tests, and compliance with regulatory standards.
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The purpose is to ensure that the product meets safety, efficacy, and quality standards and adheres to applicable regulatory requirements before it reaches the market.
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Key information includes the objectives of the development, methodologies employed, validation results, any deviations from standard procedures, and conclusions drawn from testing.
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