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Evaluation of Physician for Human Rights MediCapt Program in Kenya: Final Report September 2021Prepared by Brett D. Nelson, MD, MPH, DTM&H Roseline Muchai, MA1Table of contents 1. Context ..........................................................................................................5
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Development and validation refer to the processes of creating and confirming that a particular product or system meets specified requirements and functions as intended.
Entities or individuals involved in the creation and assessment of products or systems, such as manufacturers, developers, or organizations that are subject to regulatory requirements, are typically required to file development and validation documentation.
To fill out development and validation documents, one must provide detailed information about the development process, methodologies used, results of validation tests, and any relevant data that demonstrates compliance with specified requirements.
The purpose of development and validation is to ensure that products are developed according to established standards and that they perform reliably and effectively in real-world conditions.
The information that must be reported includes descriptions of the development process, methodologies employed, test results, compliance data, and any identified issues or corrective actions taken.
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