Definition
ISA-95 (MES integration)
ISA-95 (ANSI/ISA-95 and IEC 62264) is the international standard that structures vertical integration between production systems (level 0 to 2: sensors, controllers, SCADA), MES (level 3: execution, traceability, batch genealogy, resource management, quality management) and ERP (level 4: planning, finance, supply chain). We use it as a reference framework to specify data exchanges between layers: downstream production orders, upstream production reports, material management, batch release. The standard also defines an exchange format (B2MML, XML based on ISA-95) that standardizes interfaces. On a pharma project, clean ISA-95 integration simplifies audits, accelerates MES commissioning, and limits costly custom developments to validate.
Related
- ISA-88
- MES
- ERP
- SCADA
- B2MML
- intégration verticale
Further reading
MES, ISA-95 and ERP/PLC integration in pharma: a pragmatic architecture for Swiss sites
Pharma MES architecture: the ISA-95 grid, where Werum PAS-X, Siemens Opcenter and Rockwell PharmaSuite fit, and a concrete Swiss case of perimeter re-scoping.
ISA-88 and IEC 61512: what is the relationship?
ISA-88, IEC 61512 and S88: how they relate, what changed with the 2026 edition and how to apply the models to batch architecture.
Integrating an engineering office with IT and automation
Method to integrate engineering office, IT and automation: avoid friction points and accelerate industrial project delivery.