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Posted On: 07/14/2008

UPS Wins Third Party Validation for Pharmaceutical Distribution Tool

UPS announced June 14 that it has received third party validation for its pharmaceutical distribution and information management service, UPS SampleSure.

The system was validated by BuzzeoPDMA, an industry leader in assisting with PDMA (Prescription Drug Marketing Act) compliance and 21 C.F.R. Part 11 - Electronic Records and Electronic Signatures. It was announced today from the 2005 HDMA Management Conference & Expo.

UPS SampleSure leverages the extensive technology of the UPS delivery network and ParceLink, a third party provider of a Web-based system that integrates drug sample order data, shipping information and comprehensive activity reporting.

Beginning with order entry, the system electronically captures and stores detailed order and shipment data of drug samples sent to licensed practitioners and pharmaceutical representatives. The chain of custody for each shipment is documented through encrypted electronic signatures that are captured via the UPS driver’s wireless computer, or Delivery Information Acquisition Device (DIAD). This information is then uploaded over a secure data link to ParceLink.

Password-protected data records are electronically reconciled and a proactive follow-up is triggered if missing shipping or delivery information is detected. This feature not only provides added compliance integrity, but also enhances security efforts.

The system stores the data as “electronic receipts” for up to seven years, exceeding FDA record retention requirements. Detailed information such as the name and title of the sample recipient, the drug name and quantity and strength of the drug is retained in the system for future reference. The information is available at any time via a Web-based reporting tool that provides users control of their data. Users can generate standard reports on demand or customized reports for specific internal or external needs. Exception reports can be produced to conduct in-depth analysis of shipments to identify trends and possible drug sample diversions.

The validation of the UPS SampleSure system reflects UPS’s expertise in developing a wide variety of health care distribution services. For example, UPS Supply Chain Solutions offers solutions addressing such key performance areas as regulatory compliance, customer service, cost containment and efficiency.

UPS can be found on the Web at www.ups.com.


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