1. Which validation parameters to choose?

In the literature, there is a wide variety of guides, standards and documents for validating analytical methods. In general, they consist of compiling a collection of so-called validation parameters and, sometimes, comparing them with threshold values where these exist. The approach presented here is a little different, in that it attempts to assess the confidence we can have in the future results a method will produce. This approach is based on the method's accuracy profile, which is a graphical representation and decision-support tool for validation purposes. Its construction requires a collection of measurements, carried out under well-defined conditions, which are intended to simulate the way in which a method will be used routinely.

In general, validation procedures are aimed at proving performance obligations and are organized as follows ( cf. Validating analytical...