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.
Integrating an engineering office with IT and automation
Method to integrate engineering office, IT and automation: avoid friction points and accelerate industrial project delivery.
PCS7 v7 to v9 migration: 6-phase plan for pharma
Migrating PCS7 v7 to v9 in GMP pharma without halting production: 6-phase plan, real pitfalls and field feedback.