Risk Assessment and Impact Analysis of PLC System for High Shear Mixer Granulator (RMG-600LTR)

A principal purpose of this document is to identify and evaluate the risk factor of PLC system of High Shear Mixer Granulator (RMG-600LTR) and also provides its mitigations. The purpose of the risk assessment is to minimize affect the safety, quality, reliability or durability of a product and to get maximum benefits of CGMP from PLC system of High Shear Mixer Granulator (RMG-600LTR).This document identifies the functions which may impact on patient safety, data integrity and product quality.