ISA-95 Pharma Smart Factory Architecture
Use this hub to move from isolated automation projects to an evidence-ready ISA-95 operating model that can scale across production, quality, facilities, and enterprise reporting.
Who this helps
Plant directors, IT/OT architects, automation leads, and QA stakeholders planning connected GMP manufacturing.
Authority proof
Maps shop-floor, operations, quality, and enterprise responsibilities into a single architecture language. Connects integration patterns to GMP evidence, validation, data integrity, and inspection readiness. Gives Vietnam pharma teams a localized modernization sequence instead of a vendor-only story.
Reading path
Start with ISA-95 Implementation Roadmap for Pharmaceutical Manufacturing, then use the supporting articles to validate decisions, risks, owners and implementation sequence.
How to use this page
Use this ISA-95 Pharma Smart Factory Architecture page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For ISA-95 Pharma Smart Factory Architecture, prepare the records, owners, risks and decision criteria linked to who this helps, authority proof, reading path. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.