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Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Test validity is the extent to which a test (such as a chemical, physical, or scholastic test) accurately measures what it is supposed to measure.In the fields of psychological testing and educational testing, "validity refers to the degree to which evidence and theory support the interpretations of test scores entailed by proposed uses of tests". [1]
All analytical procedures should be validated. Identification tests are conducted to ensure the identity of an analyte in a sample through comparison of the sample to a reference standard through methods such as spectrum, chromatographic behavior, and chemical reactivity. [5] Impurity testing can either be a quantitative test or a limit test.
There are different reasons for performing a round-robin test: determination the reproducibility of a test method or process; verification of a new method of analysis. If a new method of analysis has been developed, a round-robin test involving proven methods would verify whether the new method produces results that agree with the established method.
results of laboratory performance testing should connect with field performance; These connections or correlations may be based on published literature, engineering studies, or formal programs such as quality function deployment. Validation of the suitability of the test method is often required. [4]
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