Bioanalytical quality assurance: concepts and concerns

Abstract

The BioAnalytical Specialty Section (BASS) of the Society of Quality Assurance is a group of Quality Assurance professionals who have an interest and expertise in assuring the quality of bioanalytical data. This paper presents an overview of the regulatory requirements for bioanalysis and some of the topics that have been discussed by the BASS group. This initial article will be followed by more specific articles that we hope will contribute to better understanding and consistency in the conduct, audit and reporting of bioanalytical studies. Copyright © 2006 John Wiley & Sons, Ltd.