The traditional manufacturing software stack – often referred to as the ISA-95 model – is well established in a range of industries and sectors, including the pharmaceutical and medical device manufacturing industries. Companies have built structures and processes around this model that facilitate profitable production, regulatory compliance, and effective quality control.
However, hierarchical structures like the ISA-95 manufacturing stack are becoming less and less common in the modern and increasingly digitalised world. What does this mean for manufacturers in the life sciences sector?
Flattening the Stack
In the latest whitepaper published on our website, my colleague and SL Controls Chief Technology Officer Paul Clarke puts forward compelling arguments to move away from the traditional hierarchical structure to a flatter software stack. You can read the whitepaper here.
Paul’s conclusions are based on the operational requirements of manufacturers in the life sciences sector today and in the future, as well as the modern Full Stack OT (operational technology) Platforms that are now available.
A good example of a Full Stack OT Platform is Ignition by Inductive Automation. The Ignition platform offers both SCADA and MES functionality and, crucially, there is no compromise. In other words, you don’t need to compromise on SCADA functionality to achieve MES capabilities and vice versa.
The Benefits of Combined SCADA and MES Solutions
At SL Controls, we have a lot of experience implementing Full Stack OT Platforms like Ignition in life sciences sector operations, and we have experience of the benefits this type of solution brings. Those benefits include:
- Solving connectivity issues between systems and equipment at the plant and enterprise level with those on the factory floor.
- Achieving support for increasingly common protocols, including MQTT (Message Queuing Telemetry Transport).
- Streamlined and more efficient regulatory compliance, especially in relation to audit trails and document control.
- Simplified and flexible cloud integration and the associated benefits that cloud integrations bring.
- Enhanced manufacturing analytics with digestible and actionable dashboards.
- Reduced process complexity.
- Improved OEE (overall equipment effectiveness).
- Reduced costs, including operational, training, licensing, and hardware costs.
The Next Steps
Whether you are looking for a new SCADA solution or want to enhance your operations by improving the integration between IT systems and OT systems (known as bridging the IT/OT gap), it is beneficial to consider a combined platform – a Full Stack OT Platform.
In the whitepaper mentioned earlier, Paul says the first step in the process is to define what is required. This includes clarifying what you want to achieve with the project today and in the future. Getting a full understanding of your current infrastructure is also important, both the systems and hardware that make up your IT infrastructure and the equipment and systems that come under the OT heading.
As part of the above process, it is essential to identify the legacy systems that need to be retained and integrated into the new platform.
The above is all in addition to assessing the resources and budget you have available, as well as the consultancy, planning, engineering, validation, and compliance support you will need from an experienced and certified integrator like SL Controls.
To find out more and to discuss the advantages that Full Stack OT Platforms can bring to your pharmaceutical or medical device manufacturing operations, get in touch with us at SL Controls. Or you can email me directly on [email protected].
