Analyst LC/MS Software and 21 CFR Part 11 Regulations

The purpose of this paper is to present an approach to assist the user in meeting 21 CFR Part 11 compliance with Analyst^® LC/MS Software version 1.2 and above, including Analyst Software 1.4.1, when used in quantitative studies supporting Good Laboratory Practice (GLP) bioanalytical studies. In this paper, we outline the joint responsibilities between a supplier and its customers to support users’ 21 CFR Part 11 compliance.