2024-02-29 23:00:00
The validation of methods results from the implementation of quality assurance systems in the analytical laboratories. Its initial goal is to create a relationship of trust between a service provider and a customer. Perceived at first as a constraint, it quickly became an important issue, because analysts were used to working quite independently. This attitude quickly disappeared because the laboratory had everything to gain from providing results in which the requester-decision maker could have confidence. Moreover, this approach has been very successful since the demand for analyzes of all types has only increased, and it is not over. Analysts have therefore become validation experts in just a few years. However, we must distinguish between internal validation (in-house validation in English) and external validation.
Historically, different internal validation procedures have been implemented sectorally, with water analysis specialists believing that they did not have the same problems as those in the steel industry. This is why there are still gray areas in the definitions. Consequently, several method performance parameters are subject to interpretation. The best example is that of the quantification limit: it is widely used even though there are several dozen calculation methods which result in different values. Better standardization of the methods for calculating quality criteria is certainly the approach that will resolve these problems.
Moreover, this is what happened for external, or inter-laboratory, validation. As we will see, the principles of conducting studies and the related calculations are all the subject of various international standards. They also use dedicated statistical methods.
Finally, validating a method means carrying out standardized statistical calculations. This remark is not accidental, since this standardization effort is linked to obvious economic and technical concerns. Indeed, progress in analysis methods, and the confidence that we were able to quickly place in the results, mean that they have become essential decision-making tools during commercial exchanges, or environmental diagnosis. or medical. So, the main objective of external validation is to provide means that ensure good comparability of measurements, preferably at the international level.
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