Track and Trace System: Real-Time Authentication & Blockchain Security

Pharmaceutical serialization track and trace, as delivered by OPOC Solution, assigns a globally unique serial number to each saleable unit and tracks that identifier through every touchpoint. The process begins at the packaging line, where OPOC’s vision systems verify printed 2D Data Matrix codes (ISO/IEC 15415 grade A or B). A contract manufacturing organization (CMO) in Ireland used OPOC’s serialization solution to serve six different brand owners, each with distinct formatting and reporting requirements. The system dynamically switched between serialization schemas without line stoppage, increasing overall equipment effectiveness (OEE) by 12%. After serialization, the aggregation module links each unit to its case and pallet. During a 2023 recall simulation for a cardiovascular drug, the CMO identified the affected 5,000 units out of 2.2 million in 17 minutes, compared to an industry average of 22 hours. OPOC’s serialization engine also supports “rework” scenarios: if a printer produces a damaged code, the system automatically assigns a new serial number and invalidates the old one in the repository. Real‑world data from an Italian pharmaceutical packager showed that serialization‑related line rejects dropped from 1.8% to 0.3% after OPOC’s camera calibration and lighting optimization. The solution maintains a tamper‑evident audit log compliant with 21 CFR Part 11. For manufacturers looking to implement serialization for the first time or upgrade existing systems, OPOC Solution provides a fixed‑price assessment package. To request a quote and a sample serialization schema, please contact our serialization experts.