Build, upgrade or modernize your pharmaceutical serialization infrastructure with a scalable DSCSA-focused solution from Jekson Vision.
Jekson Vision provides integrated serialization, aggregation, vision inspection and enterprise traceability solutions for pharmaceutical manufacturers, CMOs, CDMOs and packaging operations in the United States.
Whether you are implementing serialization on a new packaging line, upgrading an existing system, replacing an existing solution, adding aggregation or connecting line-level serialization with enterprise traceability systems, Jekson can help you design an architecture suited to your operation.
The Drug Supply Chain Security Act (DSCSA) establishes requirements intended to enable interoperable, electronic tracing of certain prescription drugs at the package level as they move through the US pharmaceutical supply chain.
For pharmaceutical manufacturers and other applicable trading partners, serialization and traceability form an important part of the broader DSCSA framework.
Jekson Vision provides the hardware, software, vision inspection and integration capabilities needed to create a connected serialization and traceability environment.
A successful DSCSA implementation is not simply about printing a serialized code.
The packaging line, serialization software, aggregation process and enterprise traceability infrastructure need to work together.
Jekson can provide solutions across this architecture.
Line-level equipment for serialization printing, 2D DataMatrix printing, barcode verification, OCR/OCV, product tracking, reject management and serialization commissioning.
Coordinate serialization activities across individual packaging lines and production environments.
REETRAK provides line and site-level serialization and aggregation capabilities, supporting serialized production data and packaging hierarchies.
REESOURCE provides enterprise-level traceability and is designed to connect serialized product information across manufacturing, warehouse, distribution and enterprise environments.
Connect traceability information across multiple sites, systems and supply-chain processes.
One architecture. Multiple levels. Scalable as your requirements grow.
Serialization identifies individual pharmaceutical packages.
Aggregation establishes the relationship between serialized packages and higher packaging levels.
Jekson provides integrated serialization and aggregation solutions designed to capture these relationships and maintain traceability information throughout the packaging process.
Aggregation can allow higher packaging levels to be associated with the serialized products contained within them, supporting efficient handling and traceability of serialized products through packaging and distribution operations.
Serialized pharmaceutical products require accurate and reliable identification.
Jekson's vision inspection systems can verify machine-readable and human-readable information printed on pharmaceutical packaging.
The process can be integrated into the packaging line:
This helps prevent incorrect, unreadable or mismatched information from progressing through the packaging process.
DSCSA involves more than physical serialization.
The broader framework includes interoperable electronic tracing and exchange of product information between applicable trading partners. FDA has issued guidance addressing standards for interoperable exchange of information for tracing certain human, finished prescription drugs.
A serialization architecture therefore needs to consider both:
Jekson's architecture can connect packaging-line serialization with site-level and enterprise traceability systems.
REETRAK provides line and site-level serialization and aggregation capabilities within Jekson's traceability ecosystem.
REETRAK can form the serialization and aggregation layer between packaging-line equipment and the broader enterprise traceability architecture.
REESOURCE provides the enterprise-level layer of Jekson's traceability ecosystem. It is designed to connect serialized product information across manufacturing, warehouse, distribution and enterprise environments.
Yes. REESOURCE is designed to integrate with existing enterprise systems and packaging-line infrastructure.
This allows manufacturers to connect serialization and traceability information with their existing technology environment.
Many pharmaceutical manufacturers already have serialization equipment or software in place.
Jekson can conduct a line study of your existing system and recommend the most appropriate approach.
Depending on your requirements, this could include:
Upgrade suitable existing equipment with new serialization, vision inspection or aggregation capabilities.
Replace an existing serialization solution with a new Jekson architecture.
Add a Jekson serialization line as your production capacity expands.
Integrate Jekson systems with suitable existing packaging equipment and enterprise infrastructure.
The objective is to achieve the required functionality while minimizing unnecessary cost and disruption to your operations.
DSCSA requirements can become part of a larger packaging-line modernization or plant expansion project.
Depending on the project, the solution can include:
This allows serialization to be considered as part of the complete packaging and traceability architecture rather than as an isolated machine.
