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Development and Validation of the Childrens Voice Handicap Index10 for Parents *Andrea RicciMaccarini, Vincenzo De Maio, Thomas Murry, and Antonio Schindler, *Cesena, yNaples, and xMilan, Italy, and
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Development and validation refers to the processes used to ensure that a product, particularly in the pharmaceutical and biotech industries, meets the required specifications and functions correctly before it is brought to market.
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Manufacturers of pharmaceuticals, medical devices, and other regulated products are required to file documentation regarding the development and validation of their products with the relevant regulatory authorities.
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Filling out development and validation documentation typically involves providing detailed information about the product design, testing methods, results of validation studies, and compliance with regulatory requirements.
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The purpose of development and validation is to ensure that a product performs safely and effectively as intended, fulfilling regulatory standards and protecting consumer health.
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Information reported should include the product description, design methodology, validation protocols, test results, statistical analyses, and conclusions that demonstrate product reliability and safety.
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