Technical / White Paper
White Paper: Is My Method Still Valid?
The goal of method validation is to provide proof that data from each individual sample is indicative of the actual batch content with little deviation. This paper outlines the importance of validation as well as the official requirements, including characteristics to be validated & minimum requirements.
While these requirements are not mandatory for earlier steps in development, generating low-quality data can lead to poor development decision making. Therefore, method developers should provide users with verification results and ensure that users have a clear understanding of method limits.