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What is development and validation of?
Development and validation refer to the processes involved in creating and testing a system or product to ensure it meets specified requirements and performs effectively.
Who is required to file development and validation of?
Typically, organizations or individuals involved in the development of regulated products, such as pharmaceuticals and medical devices, are required to file development and validation documentation.
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Filling out development and validation documentation involves providing detailed information about the development process, testing results, compliance with standards, and any other required data as specified by regulatory authorities.
What is the purpose of development and validation of?
The purpose of development and validation is to ensure that products or systems are safe, effective, and reliable before they are made available to the public or market.
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Information that must be reported includes development methodologies, test plans, results of validation tests, risk assessments, and compliance evidence with relevant regulations.
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