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Article published online: 20240305 THIEMEOriginal ArticleDevelopment and Validation of a Natural Language Processing Algorithm to Pseudonymize Documents in the Context of a Clinical Data Warehouse
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What is development and validation of?
Development and validation refer to the processes of creating and verifying a system, product, or process to ensure it meets specified requirements and performs as intended.
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Typically, manufacturers, researchers, and organizations involved in product development and regulatory submissions are required to file development and validation reports.
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To fill out a development and validation document, one must provide detailed information on the objectives, methodologies, results, and conclusions of the development and validation process.
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The purpose is to ensure that the product or system is safe, effective, and compliant with regulatory standards before its market introduction.
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Information to be reported includes the scope of development, methodologies used, results of validation tests, risk assessments, and compliance with relevant regulations.
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