California Express

Incorporating the expertise of the industry’s leading solution providers, California Express is an integrated framework that helps pharmaceutical manufacturers, co-manufacturers, distributors and re-packers streamline serialized ePedigree compliance.

Although the final deadline is a few years away, California’s pharmaceutical mandate for serialized ePedigree is quickly turning into the catalyst for moving the industry’s product security initiatives forward.

But why the urgency?

California is the first state to require that companies create a unique serial number for each saleable unit sold within its borders. This serial number—the key piece of data that enables the recording of every step in the chain of custody along the supply chain—must be created and maintained in an interoperable electronic system, along with the electronic pedigree.

And because California is the largest market in the United States, the negative financial impacts of not being able to sell into the state are staggering. Plus, other similar state, federal and international mandates currently are in the works and will likely be launched soon.

If you’ve already started down the full compliance path with serialization pilots and pedigree systems, you may already have an understanding of the hurdles that you face moving forward. But, if you have yet to begin your implementation, achieving compliance will depend on quickly:

• Forging a cross functional team with executive sponsorship and support
• Asking the right questions to put together a full compliance plan that incorporates business strategy, trading partner on-ramping, implementation planning and deployment

The to-do list may seem overwhelming, but it doesn’t have to be.

The California Express Solution Team has pulled together its wealth of intellectual resources and market-leading enterprise components to help you easily and effectively overcome the challenges of deploying an effective patient-safety strategy—without disrupting your business.

In 2007, the market leaders in the application of serialization and ePedigree to each area of the manufacturing enterprise began developing a framework that could be applied to the problem globally—while leveraging the existing enterprise application infrastructure.

The best-of-breed solution framework, which is optimized for SAP environments, starts with an enterprise strategy for compliance. It combines 2D- and RFID-enabled printed packaging and packaging line systems technology with the leading serialization and ePedigree solutions—and is integrated into existing ERP and enterprise applications.

Minimize Risk and Time to Serialization Compliance

The California Express Team offers global service delivery capabilities, including:

• World-wide regulations and compliance tracking
• A proven methodology supported by a global project management office
• Knowledge and experience across all supply chain components
• SAP serialization and ERP integration
• Leadership in EPCglobal/GS1 standards leadership

California Express Team Members

Acsis, Inc.	PharmaTrak serialized distribution solution SAP Auto-Id enterprise integration
HP	Global strategy and service delivery HP secure printing solution
Nosco	Pre-serialized packaging solutions (2D-barcode and RFID)
Systech	Packaging Execution Systems (PES)
SupplyScape	Global serialization strategy consulting Serialized product pedigree solution
Verisign	Global serialization strategy and services

 

The California Express team is cross-trained on all solution components, works on common issues, such as serial number structures, and provides educational workshops and webinars to the industry. The team also has specific expertise and focus on solutions for SAP customers and the deployment of the SAP enterprise serialization infrastructure.

New in 2008: the California Express team has two facilities demonstrating the integration of the market-leading, production-ready serialization solutions that support complete compliance with the California legislation. For more information, contact Acsis at (856) 673-3000.

Acsis: Enabling Distribution/Warehousing Execution Systems
Once the product moves off the packaging line, are you able to effectively handle item-to-case-to-pallet aggregation hierarchies? Are you managing these serialized parent-child relationships across the distribution network? And can your systems support everything from full pallets to mixed totes and cases?

To help you answer “yes” to these questions, Acsis developed PharmaTrak, a proven first-of-its-kind serialized distribution application designed for the warehousing and distribution operations of pharmaceutical manufacturers, co-manufacturers and repackers running SAP.

PharmaTrak orchestrates, automates and tracks intra- and inter-enterprise movement and storage of finished goods through serialized barcodes and RFID tag labeling. This preconfigured product leverages the Acsis xDDI technology platform for business process automation and data collection—offering manufacturers and distributors a clear path to ROI through enhanced supply chain execution and visibility.

Learn more about Acsis PharmaTrak (pdf).

Learn more about implementing an ePedigree plan (pdf).

Read Acsis customer success stories.