7.22 Summary
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Validation should cover sample preparation, measuring instrument, software, processing of the results and analyst competences. Analytical parameters of methods are
calculated with the use of measurement results, and the resulting data are processed
using appropriate statistical methodology. Validation should be conducted under conditions used for the testing of routine samples in the laboratory, most preferable with
the use of samples deliver by clients.
Validation should be repeated in respect to the most critical parameters of the given
measurement procedure, whenever something changes significantly in the conditions
of the measurements (e.g., a new instrument, new software, a new type of objects, a
new standard, new analyst).
The scope of the primarily validation and re-validation should be tailored so as
to consider the intended purpose of the measurement procedure and the final use of
the result, bearing in mind the cost and the risk of obtaining erroneous results.
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