The role of validation in the life cycle
Validation of quantitative analytical methods by means of the accuracy profile
Article REF: P224 V2
The role of validation in the life cycle
Validation of quantitative analytical methods by means of the accuracy profile

Author : Max FEINBERG

Publication date: December 10, 2012, Review date: May 23, 2023 | Lire en français

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1. The role of validation in the life cycle

1.1 Concept of a method's life cycle

First of all, we need to clarify when a method needs to be validated. Indeed, like any process, analysis methods are born, evolve and disappear; this journey can be summarized in the form of a life cycle, a concept already widely used in the systems approach. Figure 1 summarizes the life cycle of an analysis method. By convention, the main stages and sub-stages are represented in rectangles, and the associated tools as ellipses.

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