Meeting 21 CFR Part 11 Requirements

Abstract: Food and Drug Administration (FDA) introduced 21 CFR Part 11 (Part 11) regulations to promote wide usage of electronic technology in the life sciences industry in a way that is compatible with FDA's responsibility to protect public health. MetricStream, the leading provider of compliance and quality management solutions to life sciences companies, has designed its software to enable customers to streamline internal operations and procedures while fully adhering to the Part 11 regulations. This paper discusses specific MetricStream solution capabilities that address the Part 11 requirements.