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C Program Files CMC Opinion Processing OpinEditArea Coxmemo Ustaxcourt  Form

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five things you need to know about CSA the first one is we have been preparing risk assessments for years that look at our business risk and our risk of not meeting a regulatory requirement and what we've missed is at the end of the day there's a patient that's going to be using this product so CSA moves that line back and it says focus on the risk to the patient safety and product quality and then map that to the return requirements implementation cut the complexity out of the box configured custom that drives your testing and your risk number two there it calls for the least burdensome documentation approach we don't need 3,500 pages test 3,500 page test cases we don't need 5,000 screen prints I know in the past I've done them I've done those three in the morning still working on executing test cases right so it reduces testing paperwork by 80% when you focus on unscripted and ad hoc testing and I want to be very clear here unsc

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