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Compliance of Quality Management Systems with 21CFR Part 11 - a detailed analysis

Abstract: This document describes how MetricStream's EPM Platform v3.3 and Quality Management System, the quality and Compliance management software is compliant with the regulations in the Food and Drug Administration's 21 CFR Part 11 for electronic records and electronic signatures. We shall discuss in detail and explain how MetricStream software is compliant with these requirements. In addition, we shall also specify when the customer must have specific processes in place to comply with all the needs of the Code.