Let us start with method validation, which has crucial importance in lab workflows. In fact, method validation considers all the possible effects or factors of influence on the final result and makes them traceable. Moreover, method validation finds all uncertainties of measurement and all effects associated with it within the specifications.
Therefore, let us analyze the concept of acceptable standards of accuracy: a result cannot be interpreted without a statement of uncertainty, and therefore before calculating measurement uncertainty the result has to be traceable and fit a reference or standard which is assumed to be true.
Measurements are supposed to provide us the quantitative knowledge about things and phenomena. Therefore, validation confirms the fitness-for-purpose of a specific analytical or empiric method. Given this circumstance, ISO standards involve confirmation by examination and endorsement by objective evidence that the requirements and specifications have been respected and fulfilled.
The LIMS software must react quickly to fulfill the requirements as well as cover the customers’ demands. LIMS software, such as [FP]-LIMS, is designed to manage analyses and, therefore, fulfill the specifications to investigate analytics. On the evidence that the objective of validation has been taken into account, we can affirm that validation has the task to measure the different effects, that influence the result, and to make sure that there are no other effects that can be considered.