TAGSYS Methodology To Help Pharma Meet FDA Guidelines On RFID

Doylestown, PA - TAGSYS recently introduced the industry's first methodology to assist customers evaluate, design and deploy a scalable end-to-end item-level RFID infrastructure that delivers six sigma performance and reliability. P3: e-Xecute RFID is a consultative step-by-step approach that maps out the entire project roadmap based on customers' objectives for RFID in the manufacturing line and supply chain. Using intellectual property and best practices developed by TAGSYS, P3: e-Xecute RFID takes customers from design through the delivery of a fully integrated infrastructure in as little as three months.

With RFID technology maturing and a growing number of item-level initiatives in numerous industries, including pharmaceutical and life sciences, retail, fashion, and close looped sectors like libraries, RFID is increasingly used to automate labor-intensive processes, authenticate and safeguard goods, and enable real-time inventory and asset visibility. Anchored by TAGSYS' Reliable, Accurate and Secure (R.A.S.) RFID products, the methodology leverages TAGSYS' partner network to take a technology agnostic approach to engineering item-level RFID systems based on a client's specific business requirements.

"Whether to protect patient safety in the healthcare sector, brand equity in the fashion industry, or improve efficiencies in the consumer packaged goods supply chain, the business value of item-level RFID is becoming clear," said Elie Simon, CEO of TAGSYS. "P3: e-Xecute RFID is a technology agnostic approach that was developed to help customers understand not only the value of RFID in their business but also that RFID can be easily integrated into existing production lines and the supply chain with minimal, or in many cases, no disruption."

P3: e-Xecute RFID as a Springboard to RFID Deployment in the Pharmaceutical Sector
Drug counterfeiting and diversion (the practice of fraudulently obtaining prescription drugs and reselling them), has created an increasingly dangerous problem in healthcare. As a result of this, the FDA has established guidelines favoring the use of RFID technology as an effective tool in protecting the pharmaceutical supply chain, and ultimately patient safety.

However, the requirements of read rate accuracy and product quality in the pharmaceutical sector are extremely high and production lines very complex. The industry demands six sigma levels of performance, i.e. 99.9999% readability and a maximum of three in a million failures. To facilitate this, the P3: e-Xecute RFID methodology provides a tested and reliable process that is proven to achieve the highest levels of performance in even the most demanding production lines. P3: e-Xecute RFID is currently being piloted by several large drug manufacturers.

"Commenting on the challenges that the pharmaceutical sector faces when implementing RFID, Laura Ramos, vice president of Forrester Research's Healthcare and Lifesciences research group writes in a December 2005 report, TAGSYS Helps Pharma Firms Reduce RFID Packaging Line Challenges: ‘Unlike early retail efforts with RFID, "slap and ship" will not work in pharma... Integrating RFID technology and data collection into existing manufacturing lines requires running onsite pilots with flexibility and a keen understanding of pharma process requirements, both of which drug manufacturers can underestimate in time and effort… While RFID is only one technology drug firms can use to secure product authenticity and fight counterfeiters and thieves, early adopters will partner with RFID technical experts like TAGSYS."

Steps to Achieving an End-to-End Infrastructure
P1: Proof of Product, begins with an analysis of the customer's business case. TAGSYS' engineers and consultants scope the project's business requirements, e.g. a customer may require 99.9999% read rate accuracy in densely packed items of liquids with several different SKUs. Based on the requirements, TAGSYS develops product specifications and integration needs with the customer's existing systems. Upon completion of the P1 phase, customers have an analysis of their business case and requirements, and tag and RFID station recommendations that meet those requirements, including protocols, frequencies, form factors, read/write capabilities, readers, antennas, and interfaces.

During the P2: Production Proof of Concept phase, TAGSYS designs and tests the implementation of the RFID infrastructure in the customer's manufacturing, production or packaging line. With the technical specifications on hand, TAGSYS works with customers on placement of tags, either as a converted label or embedded in the packaging. The tag could be embedded in a plastic or glass bottle or within the safety cap of medical vials. Additionally, TAGSYS assesses and recommends what information is stored on the tag. Finally, TAGSYS undertakes cradle-to-grave tests through production modeling and lab based unit testing to replicate actual deployment scenarios where all critical interactions throughout the supply chain are tested and troubleshooting can occur pre-deployment. At the completion of this phase, customers will receive an analysis of feasibility as well as functional design that include RFID tag and station specifications, data interface requirements and business rules.

In the final phase, P3: Production Execution, TAGSYS enables the system on site at the customer's facility. This process includes installing RFID hardware and integrating the solution into the existing system line. TAGSYS performs end-to-end integration testing and certifies the line for a live roll out.

SOURCE: TAGSYS