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While California’s law has defined what needs to be done, it provides no guidance on how this industrywide system should be implemented. This has led to confusion in the industry as standards continue to evolve, technology vendors provide conflicting information, and trading partners announce their own specific expectations.
And to add to the urgency, at least one of the “Big Three” drug wholesalers has issued requirements to manufacturers stating that their products need to be appropriately serialized by mid-summer 2008.
With less than a year to implement, where does a pharmaceutical manufacturer begin?
Stop talking and start doing…one step at a time.
Serialization is the first step towards compliance with California’s drug pedigree regulations and the basis for improved supply chain performance. At its most basic level, serialization consists of three activities: (1) applying a unique identifier to individual bottles of drugs and the cases that carry them; (2) capturing the relationships between those items and cases; and (3) linking the identifiers with important business information, such as master product data, invoice information or PO data.
The IBM Serialization Pilot Kit helps pharmaceutical manufacturers address this first step. The kit reduces complexity and uncertainty by breaking the problem into smaller, more manageable pieces; providing a way forward. IBM can help you start doing.
IBM Serialization Pilot Kit with TAGSYS RFID
The IBM Serialization Pilot Kit with TAGSYS RFID is an inexpensive, low-risk way to rapidly pilot and evaluate HF RFID for item-level serialization in packaging operations. This integrated offering provides all hardware, software and services needed to validate the performance, reliability and cost-effectiveness of HF RFID for this purpose.
The Pilot Kit includes the following:
- Tags: 50,000 high-frequency (HF) TAGSYS tags ready to be integrated into the product, and 1,000 ultrahigh-frequency (UHF) tags for case-level serialization.
- RFID hardware: TAGSYS HF reader stations (based on the new L400 Long Range Reader) with integrated diverters that can be easily added to a packaging line, HF/UHF stations for associating items to cases, and a UHF RFID printer to print case labels.
- Software: IBM WebSphere Premises Server software to manage the RFID data capture process, associate items with production run data, and generate serialization reports.
- Services: The necessary services to install and configure the system for optimal performance.
The Serialization Pilot Kit can be deployed in under four weeks for a simple price. With it, pharmaceutical manufacturers can learn how easily and quickly RFID can be applied in packaging operations, evaluate the accuracy and reliability of the technology at production speeds, and make an informed choice on their path to item-level serialization. Since the hardware is provided for the duration of the pilot, clients can use RFID with minimal risk and expense.
TAGSYS will provide customers with the same expertise and architecture used in its Six Sigma Performance Program, a quality-of-service program that guarantees fewer than four failures in one million read opportunities. IBM’s depth of experience in systems integration and its robust software platform ensure that customers get a proven solution that is rapidly deployable.
Finally, the Serialization Pilot Kit also provides a simple path to California pedigree compliance by upgrading to IBM’s Solution for Pharmaceutical Track & Trace. The full solution automates event capture by integrating into real-time operational systems, incorporates receiving and pick-pack-ship processes for distribution centers, and leverages IBM WebSphere RFID Information Center’s new ePedigree feature to meet California pedigree requirements and enable supply chain optimizations.
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