Gentech Process Engineering addresses the automation / controls systems that will be provided to the project. The service can be divided into two main parts: – PLC panels with automation software for general control – Delivery of various instruments / valves / equipment (components), that is to be integrated into the process piping system and that are used with each automation system The equipment will essentially follow the same DQ/IQ/OQ/PQ process, with following differences: – DQ is prepared in accordance with URS, cGMP by design team – IQ of PLC panels will be done prior to shipment – IQ of control wiring will be done at site, managed by Gentech Process Engineering and supervised by the owner. – Delivery of all components / panels will be coordinated and inspected by Gentech Process Engineering at site for damages and completeness, and after that will be installed as per planning – During system OQ’s, the components, integrated into the process piping systems, will be part of the OQ test protocols. Gentech Process Engineering needs to provide input to Owner’s Operations relating to any OQ tests that need to be defined for these components – During OQ, as many functional testing needs to be done as possible on the components, to ensure proper working – Calibration of mixing tanks load cells, an OQ activity, needs to be done for the tanks that are directly linked to the PLC panels – The control system needs to be regarded as a separate system (1 per system/technology) and needs to have its specific PQ protocol, to be defined – Gentech Process Engineering will conduct training for the users (operators).