| Abstract: | Pharmaceutical manufacturers and distributors charged with creating records of their products' movements will have a new option for integrating RFID-based pedigrees into their ERP systems. |
| Keywords: | Pharmaceutical, pedigree, e-pedigree, track and trace, RFID, counterfeit drugs, drugmakers, pharma, chain of custody, supply chain visibility, case and pallet, Acsis, SupplyScape, RFID-ERP integration |
In a bid to extend its footprint within the pharmaceutical industry, RFID purveyor Acsis Inc. this week announced a new offering that combines software, hardware, and services for pharmaceutical companies that must assiduously track the movements of their products.
The Acsis offering will combine the company's RFID technology and integration expertise with E-Pedigree software from SupplyScape Corp., which acts as a data management system for all of the transactions recorded as part of a pharmaceutical product's chain of custody.
Various state laws require drugmakers to create a transactional record for their products, called an electronic pedigree, or e-pedigree. The goal is to safeguard a supply chain that has been fertile ground for counterfeiting and misdirected product, leaving consumers at the mercy of dangerous, untested substances. In its December 2006 Compliance Policy Guide 160.900, the Food and Drug Administration defined a drug pedigree as "a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them."
Thus, the manufacturers and distributors involved in getting prescription drugs to pharmacies and hospitals must create ways to tag those drugs and monitor their progress through the value chain, while managing the associated data efficiently.
The Acsis offering "is a completely automated serialization of the pharmaceutical packaging and distribution process to conform with e-pedigree mandates and laws in a very scalable way," Andre Pino, vice president and chief marketing officer of Acsis, told Managing Automation in an interview.
Acsis applies RFID tags to cases and pallets of drugs, serializes them, defines which cases are assigned to particular pallets, and manages the data that flows to and from a customer's ERP system and the e-pedigree software as the products make their way through the distribution process.
To create this information flow, Acsis deploys its service teams to integrate the RFID tags, the customer's ERP system, and the SupplyScape E-Pedigree software. The heart of that integration is Acsis' xApp for Device and Data Integration (xDDI), services-oriented architecture (SOA)-based software that uses SAP's xApp infrastructure. xDDI provides a single platform for device and data integration and allows interaction among all the devices involved: RFID tags, readers, printers, and the ERP system and SupplyScape software, Pino said.
"What we do is we feed SupplyScape's E-Pedigree software with the information that it needs to create the chain of custody," he explained.
Because SupplyScape is a leader in e-pedigree software, according to Pino, and because Acsis had already been working with the company, SupplyScape was a natural partner in this effort, he said. Neither company will be selling the other's products, however, and SupplyScape will continue to maintain partnerships with other RFID providers.
Acsis has already deployed RFID-based e-pedigree systems for "a couple of customers," according to Pino. Most of the ERP systems in Acsis' pharmaceutical customers are likely to be SAP, he said, but noted that Acsis will create integration regardless of the brand.
RFID is not currently mandated as part of the e-pedigree process, but the FDA has endorsed the use of the tagging technology. In a report issued last year, the FDA Counterfeit Drug Task Force stated, "RFID is a promising technology as a means to achieve electronic pedigree (e-pedigree)."
And although no RFID-based mandates are looming at the federal level, California is on course to force the issue for many manufacturers. The state has enacted legislation, effective Jan. 1, 2009, that compels companies distributing pharmaceutical products in the state to tag those products with unique identifiers housed either in a bar code or an RFID tag.
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