ISA-95 Level 4 ERP Integration

ISA-95 Level 4 (ERP) integration services for pharmaceutical manufacturers. The engagement covers the order management, the inventory integration, the costing, the master data sync, and the reporting.

Order management

The order management covers the order creation, the order release, the order tracking, the order completion, and the order reporting.

Inventory integration

The inventory integration covers the material master, the inventory levels, the lot tracking, the expiry, the movement, and the reconciliation.

Costing

The costing covers the material cost, the labor cost, the overhead, the batch cost, and the product cost.

Master data sync

The master data sync covers the material master, the customer master, the vendor master, the BOM, the routing, and the recipe.

How to use this page

Use this ISA-95 Level 4 ERP Integration 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 Level 4 ERP Integration, prepare the records, owners, risks and decision criteria linked to order management, inventory integration, costing, master data sync. 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.

Frequently asked questions

Which ERP systems are commonly used in pharmaceutical manufacturers?

Common ERP systems include SAP, Oracle, Microsoft Dynamics, and Epicor.

Is the ERP integration validated?

Yes, the ERP integration is validated per the GxP validation strategy.