Epedigree in the Pharmaceutical Supply Chain - Pharmaceutical Technology

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PharmTech Europe

Epedigree in the Pharmaceutical Supply Chain
The author examines the current regulatory and legislative framework for ePedigree for finished drug products as well as proposals to require electronic statements for pharmaceutical ingredients.

Pharmaceutical Technology

Tools for integration

Connectivity and interoperability between suppliers and their customer are two issues to consider when trying to create an custody-tracking solution. "Companies face the need to share data and increase visibility within the supply chain but are reluctant to increase their investment in technology," says Pease. "Making an additional investment in eCommerce infrastructure often means increased costs and resource drain as a result of building an in-house solution or burdening existing systems for connecting a company with its trading partners."

Enterprise-resource planning (ERP), EDI, enterprise application integration (EAI), and other business-to-business applications may be used to link systems together. As the complexity of the supply chain increases, however, a supplier has to consider how these systems can be linked. "Companies may find themselves having to decide among undesirable alternatives," says Pease. These alternatives may include the following:

  • Change business relationships, discontinue and/or restrict distribution, or assume additional risks
  • Continue existing supply-chain relationships while adding manual processes that increase costs and delay delivery
  • Implement complex, expensive hardware and software solutions that require dedicated information technology resources that may not scale.

"No company wants to disrupt business processes, introduce delivery delays, increase operating expenses, and potentially reduce revenue," says Pease. "Organizations' legacy systems such as EDI and flat-file transfer are no longer enough. Low-level connections that only transfer batch files between applications and trading partners are giving way to smart networks that incorporate diverse integration functionality that provide integration with business processes and ERP systems," he says.

Instead, Pease points to the value of software-as-a-service (SaS) delivery model. SaS is a delivery model for business-processes integration among trading partners. Figure 1 outlines a custody-tracking solution. The hosted, managed service allows suppliers to send and receive documents electronically without having to make an additional investment in e-commerce infrastructure or upgrading existing systems. The product custody data is transmitted straight to their respective backend systems. The solution can be delivered as a portal or as a fully integrated service to translate and validate data to make it readily usable by in-house systems. To maintain data integrity throughout the supply chain, the offering should provide a central repository to ensure the safety of data so that the products' custody information can be tracked across the supply chain, without impacting trading partners' IT infrastructures and business processes, explains Pease.

The SaS model is an alternative to deploying cross-enterprise integration software or developing an in-house solution. Rapid deployment, accessibility, flexibility, and scalability are advantages of such an approach, says Pease. A typical deployment may be operational in several weeks. All participants should be able to communicate via a single connection and may use a platform using business-to-business applications, EAI, ERP systems or a secure portal for tracking transactions. The solution can also add process-automation features such as generating e-mail notifications in the case of incomplete or incorrect transactions. Transactions can either be resubmitted or corrected manually via the secure portal. The system also creates an audit trail and a searchable archive of critical data.


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