Pharmaceutical Industry Solution
Every pill, fully trackable
Comprehensive pharmaceutical serialization and traceability solution. Compliant with NMPA, DSCSA, and EU FMD regulations across the entire drug supply chain.
Core Application Scenarios
FAQ
Which core regulations must a pharmaceutical traceability system meet?
The China NMPA Drug Information Traceability Standard System is the most fundamental compliance basis, requiring all drugs to establish a full-chain traceability system from production to patient. Additionally, US DSCSA (serialization + interoperable traceability) and EU FMD (safety features + drug verification system) must be addressed if products are exported to those markets. Key compliance points include: unique traceability code on each saleable unit, multi-level packaging serialization, traceability data retention in standard format (no less than 2 years beyond product expiry), and support for online regulatory audits.
What are the challenges of pharmaceutical serialization and how are they solved?
The biggest challenge in pharmaceutical serialization is accurate association at high production line speeds (typically 200-600 packs/minute). Three technical safeguards: first, high-speed industrial cameras (30+ fps) with dedicated decoding chips ensure every pack's code is accurately read; second, PLC-linked control ensures precise time-window matching for association (pack codes must complete association before the current case is full); third, AI visual re-inspection verifies code clarity and association correctness after the association station. ZhiShuYun's solution keeps association error rates below 5 per million.
How to quickly retrieve traceability data during regulatory inspections?
The ZhiShuYun system backend provides a one-click audit report generation feature: select the product batch number and time range, and the system automatically aggregates all traceability data for that batch — from raw material procurement to end-user sales — generating a standardized audit report compliant with regulatory inspection requirements (including data integrity declaration and blockchain notarization records). Report generation time is reduced from hours (manual) to minutes. The system also supports temporary audit-mode accounts — read-only access accounts for inspectors to see data directly.
We already use ERP for batch management — do we still need a separate traceability system?
ERP manages batch-level inventory and financial data, but a traceability system needs unit-level full-chain tracking — every saleable unit has an independent traceability code and circulation record, with precision far exceeding ERP batch management. ERP's data structure lacks unit-level traceability capability. The two are complementary. ZhiShuYun supports data integration with major ERP systems (SAP, Yonyou, Kingdee, Inspur, etc.), allowing traceability data to connect with ERP order/inventory/financial data rather than replacing ERP.