Problem: DSCSA requires verifiable unit-level chain of custody from manufacturer to dispenser. EDI files: reconciled post-facto, alterable, incompatible per partner. Reconciliation disputes required days of manual investigation. Counterfeit detection effectively impossible.
Solution: Hyperledger Fabric channel with one peer node per partner. Chaincode records manufactured/shipped/received/dispensed events as immutable transactions visible to all channel members. API gateway per partner translated ERP events (SAP IDocs, Oracle REST, flat files) into standardised chaincode calls — partners never touched Fabric directly. Private Data Collections for sensitive pricing data between buyer and seller only.
Technology: Hyperledger Fabric · Go chaincode · SAP IDoc · Node.js · Docker
Optimisation pattern: bilateral-edi-reconciliation-to-shared-permissioned-ledger-with-erp-gateway
Outcomes:
DSCSA audit: compliant. 3 suspect counterfeit units identified in first 6 months (zero in prior 2 years with EDI). Reconciliation disputes: reduced 91%. New partner onboarding: 3 months → 2 weeks.