Application Note: Analyst® LC/MS Software and 21 CFR Part 11 Regulations
23 June 2017

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, the joint responsibilities between a supplier and its customers to support users’ 21 CFR Part 11 compliance is outlined.