Life Sciences industry is going through accelerated changes in business model, to be able to introduce life saving drugs quicker and more effectively in the market. The business model includes close integration of new drug discovery, R&D, clinical process, manufacturing process, storage and delivery processes. Integration of each stage of product life cycle can only be harmonized by utilizing the control standard S88. Once each process is internally controlled via automation, the integration of each process to its surrounding processes is achieved via combination of S88 and S95 standards. This allows a model and terminology consistency within the product life cycle containing manufacturing systems, enabling them for a vertical integration to ERP readiness for business excellence.

The business model with enterprise ERP level solutions was a main focus for quite some time. The Manufacturing automation and integration of the manufacturing floor to ERP with near real-time information were not integrated part of the thought process in 1980s and 90s. IT and operations had separate systems that required manual or islands of customized data transfer between these two distinct worlds. What we see in the life sciences industry today is the change of priorities. Processing industry is realizing that the product lifecycle management including manufacturing automation must have a visible, high priority to achieve excellence both in business and operations. Technology is now available to achieve this excellence by applying it to processes with people. Every Global enterprise is making Manufacturing Automation and Integration a major part of the next generation solution. This is absolutely necessary to reach high agility and responsiveness to changing market requirements. Business system automation is not complete until the manufacturing system is automated and linked to the business system properly. ISA organization developed Batch Control Standards called ISA S88 and released part 1 in 1995. This was a necessary step to optimize the batch process control level manufacturing system. It defined the object oriented model and the terminology for the batch process automation. The next step for excellence was to kick off a standardization committee for Enterprise to Control Integration. Business layer and control layers are separately automated, but not directly integrated. It was absolutely necessary to close the gap between these two Worlds. We started seeing global initiatives from all the major life sciences corporations to integrate the systems to globally close the loop. However, the focus of integration cannot be just ERP to control integrations. We need to integrate the product life cycle stages with each other similar to ERP integrating business processes.

This presentation is focused on laying out a high level functional model for Product Life Cycle process integration for ERP integration readiness by utilizing S88 and S95 standards.