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Search results with tag "Analytical validation"
CLIA-Compliant Analytical Method Validation Plan and ...
www.aphl.orgvalidation ANALYTICAL METHOD PERFORMANCE SPECIFICATIONS A. Accuracy and Precision4,5 The following is a hierarchy of recommended approaches to the establishment of requirements for the accuracy and precision of clinical analytical methods. 1. Medical usefulness requirements based on the effect of analytical performance on clinical decisions ...
Technical guide for the elaboration of monographs - EDQM
www.edqm.euMethods included in monographs must be validated as described in the chapter on analytical validation and other relevant specific chapters of this guide. Validation reports are provided to the EDQM but are not published or otherwise provided to users.