chapter  4
20 Pages

Method Validation Basics

Method validation is one part of the overall validation process that encompasses at least four distinct steps: (1) software validation, (2) hardware (instrumentation) validation/qualification, (3) method validation, and (4) system suitability, and each step is critical to the overall success of the process. Method validation establishes through laboratory testing that the performance characteristics of the method meet the requirements of the intended analytical application. It provides an assurance of reliability of laboratory studies during normal use, and is sometimes referred to as the process of providing documented evidence that the method does what it is intended to do. In addition to being good science, regulated laboratories must carry out method validation in order to be in compliance with governmental or other regulatory agencies. In addition to providing proof that acceptable scientific practices are used, method validation is therefore a critical part of the overall validation process. A well-defined and documented method validation process not only satisfies regulatory compliance requirements, but also provides evidence that the system and method are suitable for their intended use, and aids in method transfer [1-4].