What is method validation?
Method validation is a practical process designed and experimentally carried out to ensure that an analytical methodology is accurate, specific, reproducible and rugged over the specified range of analysis. Method validation provides both an assurance of reliability during normal use, and documented evidence that the method is �fit for purpose�.
Why is method validation necessary?
Method validation ensures the validity of a measurement before it is carried out and is an essential part of quality assurance procedures. The process of method validation provides information on the critical factors affecting the method output, thus enabling suitable quality control procedures to be implemented to ensure data quality. The extent of method validation will vary with applications, sectors and regulatory compliance.