About this document
Method Validation Guide for Laboratories by Quality and Safety Consultants Co. is a document available to read on EtoBox.
This document discusses method validation and provides guidance on how to validate instrumental methods. It explains that validation is required for non-standard methods to prove they are suitable for their intended use. The key performance parameters to evaluate include precision, trueness/bias, measurement range, ruggedness, and measurement uncertainty. For qualitative methods, precision is assessed by reproducibility, trueness by false positive and negative rates, and measurement range by the limit of de
- Author
- Quality and Safety Consultants Co.
- Language
- EN