Leveraging ISA-95 In A Pharma 4.0 World

By John Harrington, Chief Product Officer at HighByte

While numerous standards exist to guide companies in modeling and structuring their data, ISA-95 is one of the most globally recognized data modeling standards. For life science manufacturers with rigid compliance requirements, the universal acceptance of the ISA-95 specification makes it a robust foundation for creating a data modeling framework.

ISA-95 has been implemented in many manufacturing plants worldwide and serves as the guide for various off-the-shelf and bespoke manufacturing execution systems (MES). This standard offers several helpful models that are great starting points for implementing data integrations that connect MES, enterprise systems, IoT platforms, data lakes, and analytics. ISA-95 also simplifies the implementation of a unified namespace (UNS), a consolidated and abstracted structure by which all business applications can consistently consume real-time industrial data, for enterprise data integration.

The specification defines a hierarchal model for systems, detailed information models, and a data flow model for manufacturing operations management (MOM). This article will explain these core elements of the ISA-95 specification and demonstrate how it can be applied within the HighByte Intelligence Hub. The Intelligence Hub acts as the integration solution between systems at the same level or different levels in the ISA-95 stack. Additionally, it can populate a UNS structured to the ISA-95 hierarchy and be used to structure a data lake, data warehouse, or database using the ISA-95 models.