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LIS COORDINATOR CERTIFICATION/QUALIFICATION REQUIREMENTS

code911
in Computer Systems / Software / ISBT128

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comment_52377

Do you have to be a certified CLS , ASCP or MT to work as LIS Coordinator? If a non -licensed built the system dictionaries and has a licensed CLS validate the system, is that compliant ? I do not have a full understanding of CFR 21 part 11. Since a new LIS is considered a medical device, does it require a licensed personnel to perform the test build?

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