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AutoGenomicsINFINITI Warfarin Assay
(2C9 & VKORC1 Multiplex Assay)
Directional Package Insert (DPI)For In Vitro Diagnostic Useful EXPORT ONLYManufactured by Autonomic, Inc., 1600 Faraday Avenue, Carlsbad,
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What is validation of clinical testing?
Validation of clinical testing refers to the process of ensuring that the methods and equipment used in clinical trials are accurate, reliable, and produce consistent results in measuring what they are intended to measure.
Who is required to file validation of clinical testing?
Typically, pharmaceutical companies, clinical research organizations, and any entity conducting clinical trials involving investigational new drugs or medical devices are required to file validation of clinical testing.
How to fill out validation of clinical testing?
To fill out validation of clinical testing, one must provide detailed documentation of the testing methods, protocols, results, analysis, and any corrective actions taken to address deviations.
What is the purpose of validation of clinical testing?
The purpose of validation of clinical testing is to provide assurance that the testing processes and results are scientifically sound and meet regulatory requirements, ensuring the safety and efficacy of medical products.
What information must be reported on validation of clinical testing?
Information that must be reported includes the testing protocols, validation studies, results, statistical analyses, and any deviations or modifications to the original testing process.
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