US DSCSA Suspect and Illegitimate Product Handling System

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A critical component of the US Drug Supply Chain Security Act (DSCSA) is the ability for downstream customers and the FDA to initiate product verification requests with pharma manufacturers and other trading partners.  The purpose is to provide a mechanism for the pharmaceutical industry to better root out suspect and illegitimate product.

 

To comply, manufacturers are required to have systems in place which allow for the proper handling and execution of verification requests.  The regulation provides guidance on requirements for verification systems and other key capabilities which manufacturers must maintain in order to provide timely and accurate responses.

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Many small to medium organizations may be forced to rely on highly manual tasks and tools as use of large enterprise or ERP solutions are often not feasible.   This in turn increases the risk of non-compliance with DSCSA as verification processes often require multiple touch points with internal resources, IT systems, trading partners and government agencies.  

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To address this complexity the Jennason DSCSA Verification Manager provides a simple, cost effective solution to help pharma companies manage the entire product verification process including

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• Verification request entry

• Tracking of suspect product and illegitimate product investigations

• Response tracking and automated reminders to ensure replies are given within 24 hours where required

• Process step approvals

• Capturing of lessons learned

• Automated creation of required FDA forms

• Management of trading partner and FDA notifications

• Full auditing of verification requests

• Reporting on verification request frequency and trends

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The Jennason DSCSA Verification Manager leverages a common delivery platform as other Jennason solutions which provides

• Web accessible platform for rapid collaboration across functional teams

• Role-based user access ensures data integrity and security

• Direct integration with 3rd party systems such as ERP, regulatory and serialization platforms

• Single-tenant architecture allows for solution customization

• Easy integration with Jennason Master Data & Workflow Manager

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