As a Plant Manager responsible for a pharmaceutical production operation that is currently validated by the Food & Drugs Agency (FDA) I am being tasked to provide additional data from my processes to support Good Manufacturing Practices (GMP), facilitate an energy management campaign for ISO 50001, and other overall operational improvements.

This data includes asset , diagnostic and process data. Asset data can include things like device type codes, revisions, catalog, and serial numbers. Diagnostic data may include alarms, fault codes, memory faults, etc. Process data would be values such as pressure, flow, temperature, etc.

My current system has CIP devices with interesting data that I can use. I may also need to add a third-party device (non-CIP) to my network for additional data. I would need a gateway to collect this data and send it to a cloud for monitoring and analysis.

A variance to the risk assessment for validation protocol can be written since we are not modifying/changing the control program, any devices or functionality to the production operation. It is important that we do not have to undergo revalidation to save time and costs while retaining optimal uptime.

It is necessary to have a gateway that is secure, does not receive inputs from the cloud, only pulls data from devices, and pushes it to the cloud. This should not impact the validated process and equipment and provide a risk-free way of data collection for analysis. There must be no programming or commissioning changes required at the PLC/DCS.