As federal agencies, state governments, and the pharmaceutical & life sciences industry take measures to reduce drug counterfeiting, product diversion, and increase patient safety, drug manufacturers are faced with the challenge of implementing serialization and tracking systems for both self-interest and regulatory compliance. Serialization is the first step to ensure compliance with new ePedigree regulations coming to fruition that will require product traceability throughout the supply chain, from manufacturer through distribution and sale to the consumer.
Companies face the impossible decision of an overall “rip and replace” production line overhaul or retrofitting existing technologies and packaging lines to meet various global requirements. Xyntek’s unique global awareness of the mass serialization market, standards and current implementations combined with existing relationships with global providers that offer prevalent and available technologies makes us an ideal partner for emerging needs. Xyntek leverages extensive experience in pharmaceutical manufacturing and packaging automation and information technology to offer a suite of ePedigree and serialization (Track-and-Trace) consulting and integration services to help companies define and execute on a serialization strategy.
Consulting Services
Xyntek’s consulting services will ensure that your serialization and track & trace system is designed and implemented to meet your unique business requirements, strategic goals, business requirements, and existing technologies and systems. These services include the following:
- Serialization Implementation Strategy Plan
- As-Is Business Process & Technology Analysis
- To-Be Business Process Determination
- User Requirements and Functional Requirements Specification
- Serialization Technology Vendor Evaluations, Recommendation & Selection
- Serialization Pilot
- Serialization Project Scale-up and Implementation Project Management
- Retrofit Analysis and Implementation
Integration Services
Xyntek has focused on machine vision and process automation integration projects within the pharmaceutical sector since the early ‘90s. Coupled with our expertise in the areas of Manufacturing Execution Systems (MES) and interfacing systems from the factory floor to ERP systems, Xyntek is an ideal candidate for your emerging integration needs in mass serialization and e-Pedigree. Our integration services are necessary for seamlessly integrating technologies and ensuring validation ready solutions at the various track-n-trace levels:
- Enterprise level - Integration approach for serialization and ePedigree resulting in the integration of data points across the enterprise from shop floor to ERP to facilitate serial number aggregation and allocation, while also providing visibility into the entire process and lines for managing efficiencies. Xyntek’s expertise with technologies, including SAP Aii/OER, allows us to integrate automated communication and sensing devices – including RFID readers, printers, bar-code scanning devices, PLCs at the plant floor and provides the business context to turn the data into meaning business events.
- Line level – Implementation of Packaging Line Control solutions for process control, production monitoring, data collection, and reporting,
- Device layer – Xyntek interfaces various OEM equipment and devices from the shop floor to information systems. In addition, we offer machine vision solutions to meet various product quality and label inspection requirements.
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