Validation Criteria for Analytical Procedures
*Rick Burdick, Elion Labs 


Procedure validation is a cornerstone in the process of developing an analytical procedure. The aim of procedure validation is to demonstrate that the procedure, when run under standard conditions, will satisfy the requirement of being fit for use. In this presentation, we focus on validation of accuracy and precision. Validation criteria are proposed, that if satisfied, provide quantitative evidence that a procedure is fit for purpose. Metrics used to establish acceptance criteria include the probability of an out-of-specification (OOS) signal, the probability of a false failure, and the probability of a missed fault.