Validation and method lifecycle
External validation of analytical methods

An analytical method is a procedure, i.e., a series of more or less complex, planned operations, aiming at the determination of an analyte. From a strict metrological vocabulary perspective, the term measurand should be used, rather than analyte. However, analysts have been able to gain acceptance for the latter term, which is better suited to their discipline.

A set of ancillary resources is used to implement this measuring procedure. This is referred to as a measuring system. Analyte determination can be quantitative or qualitative.

Since most analytes are difficult to relate to a standard in the International System (SI) of units, the initial question for an analyst is to ensure that what is measured...