Other solutions
Specialized vendors are offering applications to assist in meeting ePedigree and supply-chain requirements. For example, SupplyScape
(Woburn, MA) introduced in June 2008 Nexus-enabled applications and services to its product serialization and supply-chain
optimization solutions. Nexus is a network-based data-sharing and collaboration platform to facilitate interoperability within
trading networks.
Axway (Scottsdale, AZ) offers its "Synchrony" supply chain integrity suite as a solution for supply-chain management among
life-science companies and its trading partners. The product includes capabilities for data-integrity assurance, ePedigree,
business-activity monitoring, and trade- activity management, and track-and-trace functionality.
In July 2008, rfXcel (San Ramon, CA) release its "Everest" track-and-trace platform for ePedigree and serialization compliance
and business analytics. In January 2008, Acsis (Marlton, NJ) released "PharmaTrak 2.0," a preconfigured, serialized track-and-trace
solution developed for pharmaceutical manufacturers, co-manufacturers, and distributors The software is designed to manage
serialized drug products in warehouse and distribution centers to support the ability to generate ePedigree documents, automate
product movement and transfers, as well as support track, trace, and product authentication through the supply chain.
References
1. FDA, "Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription
Drugs; Request for Comments" (Docket No. FDA-2008-N-0120), Fed. Reg. 73 (55), 14988–14991, Mar. 20, 2008.
2. FDA, "Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information"
(Docket No. FDA-2008-N-0121), Fed. Reg. 73 (55), 14991–14992, Mar. 20, 2008.
3. California State Board of Pharmacy, "Response of the California State Board of Pharmacy, Docket No. FDA-2008-N-0120, Standards
for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for
Comments" (Sacramento, CA, May 12, 2008), available at http://
http://www.pharmacy.ca.gov/laws_regs/docket_0120_comments.pdf, accessed Aug. 4, 2008.
4. California State Board of Pharmacy, "Response of the California State Board of Pharmacy, Docket No. FDA-2008-N-0121 Technologies
for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information" (Sacramento,
CA, May 12, 2008), available at http://
http://www.pharmacy.ca.gov/laws_regs/docket_0121_comments.pdf, accessed Aug. 4, 2008.
5. P. Faber, "RFID Strategy—Pharmaceutical EPedigree—Biggest Supply Chain Topic of 2008," Industry Week, Jan. 21, 2008.
6. M. Rose, "Testimony before the Senate Judiciary Committee" (Washington, DC, June 17, 2008), available at http://judiciary.senate.gov/pdf/08-06-17Mike_Rose_Testimony.pdf, accessed Aug. 4, 2008.
7. P. Spellman, "EPedigree to the Next Degree," Pharm. Exec.
28 (3), 32–34 2008.
8. G. Koroneos, "Congress to Consider National ePedigree Standards," Pharm. Exec. (online), Apr. 30, 2008, available at http://
http://pharmexec.findpharma.com/pharmexec/News/Congress-to-Consider-National-ePedigree-Standard/ArticleStandard/Article/detail/512999, accessed Aug. 4, 2008.
9. House Committee on Energy and Commerce, "Revised Discussion Draft of the Food and Drug Administration Globalization Act
of 2008" (Washington, DC, July 24, 2008), available at http://energycommerce.house.gov/FDAGlobalAct-08/RevisedFDAGA.DraftDrugSafetyTitle.072908xml.pdf, accessed Aug. 4, 2008.
|
