Progressive pharmaceutical manufacturer charges ahead with serialization software for DQSA compliance

Solutions from ROC IT Solutions, Optel Vision and TraceLink enable serialization of manufacturer’s entire product line in 2014.

tnt-case-study3_348Many pharmaceutical manufacturers are taking an incremental approach to product serialization, starting with lot-level data and then adding item-level serialization one product at a time. The goal is to be compliant with the serialization mandate in the Drug Safety and Quality Act (DQSA) when it takes effect in 2017.

Other companies see no need to wait. One progressive pharmaceutical manufacturer charged ahead to achieve full item-level serialization of its entire product line in 2014.

“Serialization protects patients,” explained the manufacturer’s director of operational technology. “It’s the right thing to do.”

Off-the-shelf DQSA solution

ROC IT collaborated with Optel Vision and TraceLink to solve the entire serialization problem for this manufacturer, from manufacturing through warehousing and distribution.

Optel Vision provides the serialization software for manufacturing, with data exchange from the packaging line to the EPCIS and ERP system. TraceLink provides a global cloud-based track and trace compliance platform that connects the supply network for serial number management, EPCIS event management, supply chain traceability and government reporting. ROC IT Solutions provides the technology for edge data capture and serialized data processing in supply chain areas such as rework, pick-and-pack, shipping and receiving. It also provides data exchange between these edge locations and the EPCIS and ERP systems.

The complete solution comprises almost all “off the shelf” products, with little customization other than integration to the existing SAP back-end system.

“There is no single vendor that can solve the entire serialization problem for manufacturers, and this manufacturer saw no reason to wait for an unproven end-to-end solution to emerge,” said Larry Hall, vice president of sales and operations at ROC IT Solutions. “Optel, TraceLink and ROC IT Solutions have proven tools and a strong track record of successful customer implementations. We’ve demonstrated our ability to work together and deliver effective solutions.”

Total implementation time was only six months.

“We were very impressed with the ROC IT Solutions team,” said the manufacturer’s director of operational technology. “They are not only good to work with, but they stay on top of everything and always deliver on time.”

EdgeTRAC™ software for track and trace

ROC IT Solutions implemented its EdgeTRAC™ software on a Windows Server Platform. Workers in the pharmaceutical manufacturer’s supply chain operation use Motorola 9190 handheld devices to scan barcode labels, and Zebra printers to print labels as needed for aggregation and rework.

The implementation includes several key EdgeTRAC software functions:

  • Picking, packing and shipping. EdgeTRAC software verifies the product, lot and quantity against customer orders and provides real-time notification of exception conditions. It aggregates serialized items and creates serialized barcode labels for the aggregated containers.
  • Serial number inquiry. Workers can scan a serialized tag and see the status of a serial number, the relationship between parent (container) serial numbers and the associated child serial numbers, and the association to shipment orders
  • Container management/rework. EdgeTRAC software aggregates items into cases or totes, combines cases or totes into pallets, combines everything into shipments, and updates the TraceLink serial number master / EPCIS system.
  • Label reprinting. The software allows on-the-spot reprinting of damaged labels.
  • Deactivation/destruction. EdgeTRAC software identifies items that have been deemed non-saleable and sends items tagged for destruction to destruction area.

100% of the product lines serialized

While ROC IT’s EdgeTRAC software supports both serialized and non-serialized product data, the manufacturer chose to serialize all of its commercial products at once, rather than following the usual practice of serializing one product at a time.

“The advantage to serializing all the products at once is that you don’t have to maintain two parallel processes,” explained Hall. “The transition to serialization can actually be less disruptive this way, and companies achieve the full benefits much sooner.”

Learn more

Contact us today to find out ROC IT serialized data capture and edge processing can help you meet the serialization mandate of the DQSA.


  • ROC IT Solutions collaboration with Optel Vision and TraceLink
  • Solves the entire serialization problem, from manufacturing through warehousing and distribution
  • Deployed on Windows Server with Motorola handheld scanners and Zebra printers
  • Implemented in six months
  • Project delivered on time and budget

Contact ROC IT Solutions

To learn more about EdgeTRAC™ or any of the ROC IT offerings, call 585.641.0035, or fill out our contact form.

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