By Beth Bacheldor
May 10, 2006—Starting July 1, Florida's pedigree law will require pharmaceutical distributors to document the chain of custody of prescription drugs in the state. On Jan. 1, 2007, a California statute with similar requirements will come into effect, and other states are considering comparable pedigree laws. Complying with those regulations will require disciplined processes that can track and document the drugs as they move through the supply chain.
To that end, Scottsdale, Ariz.-based
Cyclone Commerce and systems integrator
Axway recently introduced a software package, the Healthcare Compliance Suite, which combines several applications designed to help drugmakers and wholesale distributors, logistics providers and retailers serving the health-care market to better manage and monitor their manufacturing and distribution operations.
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Daryl Eicher, Cyclone Commerce
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Available as either stand-alone or hosted software, the suite is built on a Web-based infrastructure and includes data-translation and data-cleansing technology Cyclone Commerce received in December 2005 when it merged with Axway, formerly a wholly owned subsidiary of the Paris-based
Sopra Group. Data-cleansing tools transform data from a source system format, such as a proprietary code, into a predefined, standardized format, such as
XML or HTML, as specified in HCS and other packaged software.
Translation and staging tools operate in a similar manner; many refer to these as ETL tools, or "extraction, translation, and loading" software. With the new data-translation and cleansing-technology stack, the suite can readily accept data culled from
RFID systems, says Daryl Eicher, Cyclone Commerce's vice president of health-care and industry solutions.
"Without the investments we've made in standards and data cleansing and staging, we wouldn't have been able to say we can pull that data in," Eicher says, "but now it is possible."
The Healthcare Compliance Suite includes eSubmissions, which lets companies electronically submit documents—such as the applications drugmakers submit to get a new drug approved for use—to the appropriate agencies. Such agencies include the
U.S. Food and Drug Administration (FDA), the
European Medicines Agency (EMEA) and Japan's
Ministry of Health, Labor and Welfare.
The suite also includes the Cyclone Controlled Substance Ordering System for the electronic submission of controlled-substance documentation to the
U.S. Drug Enforcement Administration (DEA), and the Cyclone Trade Activity Manager, designed to help pharmaceutical manufacturers and distributors manage their contractual agreements.