Microbiology-PTM-OMA_Modules_1-5
Harmonization Studies: Overview
• What is a harmonization study? • A single validation that allows for certification from AOAC and an ISO 16140 approval organization (AFNOR, MicroVal, NordVal). • The study is designed to meet all the requirements need for certification including • Data requirements • Statistical analysis • Submission guidelines • The goal is to achieve optimal efficiency and avoid duplication of efforts in order to meet regulatory and product safety testing requirements. • Reference standards • Testing requirements
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