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 RESOURCE LINKS  S2sdl 2003-2025

2003-2025 Form

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all right my name is Tabby Kern and I am the director for standards development and the program manager for the evaluation protocols technical area at clsi and my job today is to walk through the framework and functions of method Navigator so what is Method Navigator um it's a product that we have and it's a very valuable tool for Laboratories developing and implementing laboratory tests but it's also useful for commercially approved tests as well it presents the different requirements and regul ations that are necessary throughout the life of laboratory tests and it layers in the clsi documents that support Meeting those requirements and regulations to provide a clearer understanding of how this product was set up I'm going to briefly walk through the two Frameworks that were used to develop the product the union of these two Frameworks supports the end goal which is producing highquality laboratory tests the ep19 test life phase model seeing here outli

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