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Wholesaler
Agreements and Audits |
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"SynTegra,
LLC's audit solution, Secure Supply Solutions (S3™), is now in
commercial use to meet the supply chain audit needs of pharmaceutical
manufacturers. While we recognize use of Radio Frequency Identification,
or RFID technology promises to address some future security and
tracking needs, our audit processes are meeting today's immediate
need to confirm pharmaceutical supply chain integrity.
In 2002
and 2003, the management team at Health Pathways, the parent
corporation for SynTegra, LLC recognized serious concerns about
the preservation of pharmaceutical distribution integrity. While
many put the focus on RFID, we recognized that broad implementation
of such technology was years away. To meet immediate needs, we
engaged numerous pharmaceutical distribution experts to create
an audit process that would verify product handling by distributors
on behalf of Pharmaceutical and Biotechnology Companies. We then
created a software system to embody the principles of our audit
process and to allow auditors to provide consistent report results.
During the test phase, we met with over 25 of the major pharmaceutical
and biotech companies to validate our audit solutions, Secure
Supply Solutions (S3™). We also gained input from additional
leading experts in the pharmaceutical and distribution sectors,
including Joint Commission on Accreditation of Healthcare Organizations,
FDA and corporate finance professionals. We then conducted eight
audits at different distribution locations to complete the audit
process "build" before commercializing the system in 2004. Today,
under contract with major pharmaceutical companies, we employ
over a dozen industry veterans as auditors.
SynTegra, LLC (formerly
known as the Integrity Solutions Division of Health Pathways,
Inc.) works with all stakeholders in the pharmaceutical distribution
chain to create effective documents and documentation of policies
and procedures. We also monitor compliance with evolving regulations,
industry guidelines, and newly negotiated Authorized Distributor
and Inventory Management Agreements. Through careful monitoring
and the resultant heightened awareness, we help clients avoid
and prevent risks of counterfeit or diverted products, maintain
good working relationships among trading partners, and assure
safe pharmaceutical distribution to America's pharmacies and
the public."
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