Copley FDA Extended Solution

Copley FDA Extended solution is an enterprise quality management system (EQMS) designed for life sciences companies. It helps organizations comply with regulations set by the U.S. Food and Drug Administration (FDA) and other regulatory bodies. The solution is tailored for medical device, pharmaceutical, biotechnology, and contract manufacturing companies. Key features of Copley FDA Extended solution include compliance with FDA 21 CFR Part 11 and Part 820 regulations, integration with Infor CloudSuite Industrial Syteline ERP, device master record/device history record management, lot and serial traceability, approved vendor management, electronic signature controls, certificates of analysis/conformance reporting, and quality control functionality. Copley FDA Extended s...