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Ensure complete serialization and lot traceability across your packaging lines.
Request a demoTechnical Overview
The Drug Supply Chain Security Act (DSCSA) mandates rigorous interoperable electronic tracing at the package level. SICORG embeds serialization directly into the packaging execution layer, guaranteeing compliance from primary packaging to pallet aggregation.
1. The Mandate for Interoperable Serialization
WHO and FDA guidelines explicitly describe pharmaceutical production as extending through receipt, processing, packaging, labeling, and completion. Treating packaging as an isolated downstream process is no longer viable under DSCSA requirements. Every saleable unit must carry a standardized numerical identifier (SNI).
2. Packaging as an Execution Layer
In SICORG, packaging is treated as a core operational execution layer. When blister packs or cartons pass through serialization scanners, the ERP instantly captures serial numbers, aggregation hierarchies, and pallet numbers, tying them securely to the electronic batch record.
- Unit-Level Tracking: Serialized data capture directly on the packaging line.
- Aggregation Hierarchy: Automatic parent-child linking from carton to master shipping case.
- Immediate Verification: Instant product verification and suspect product investigation workflows.
3. Interoperable Electronic Tracing
Compliance requires secure, secure electronic data exchange between manufacturers, wholesale distributors, and dispensers. SICORG automates Electronic Product Code Information Services (EPCIS) event generation natively.
“Serialization isn't just a regulatory checkbox; it is the ultimate proof of patient safety and supply chain integrity.” — Apurv Patil, CTO