Spotlight: California 2011 for Serialized Product Pedigrees: Why Act Now?
California's decision to extend the deadline of its electronic pedigree law until January 1, 2011 has caused companies across the pharmaceutical supply chain to quickly examine their original compliance strategies and timelines. What exactly does full compliance mean and how does it affect our planning timeline? Do we now have time to step back and focus on other business needs? How should we balance all of the serialization and pedigree project requirements? What about my trading partners? How will their decisions affect our strategy and vice versa?
California Changes Everything
California's electronic pedigree legislation impacts a business in the pharmaceutical industry across many of its operations. Unlike other states and FDA's PDMA regulations, California's Electronic Pedigree legislation requires serialization of all prescription drugs at the item level. I.e. each saleable item has a unique serial number and it requires serialized product pedigrees for all product transactions. Serialized products and serialized product pedigrees will need to be managed by companies all along the supply chain, including manufacturers, wholesale distributors, specialty service organizations (contract manufacturing, 3PL), and pharmacies.
Far from a focus on January 2011, many companies will have significant work to do starting even in 2008 to get ready. Why? Because the impacts for a business are numerous and tightly interrelated. Manufacturing and packaging systems, enterprise IT systems, internal distribution processes, contract manufacturing relationships, trade partner interoperability and distribution readiness across tens to thousands of partners. With so many moving parts in the full compliance plan, even companies who have already started with pedigree systems or serialization pilots are now feeling a new sense of urgency. This sense of urgency comes from a true understanding of the scope, complexities and significant lead times required to comply by 2011.
Is Now the Time to Act?
Forging a viable roadmap that ensures a company is ready to produce or receive serialized product pedigrees when needed requires a clear understanding of the key readiness milestones and the operational dependencies between them. Solid answers to the following questions will help ensure a strong compliance plan:
- How early does the supply chain pipeline need to be filled with serialized product and matching pedigrees based on product movement rates? What are my trading partner receiving slots for compliant products or when do I need to receive compliant products from my suppliers? How long will it take to fill my own internal supply chain? Based on current lot production schedules, when must fully serialized products need to be manufactured and packaged? Are products in the R&D pipeline accounted for?
- Does your strategy for full compliance on serialization and pedigree take into account the necessary modifications to numerous business processes and IT systems that support these business operations? Will you be able to leverage existing enterprise serialization capabilities such as those offered by SAP's Auto-ID Enterprise (AIE)? Have you factored in the interdependencies that will stretch out deployment timelines?
- Have you fully assessed the use cases and impact of serialized pedigree on your strategy to accommodate unit serialization? Whether you're a manufacturer determining serial number construct and data carrier options, or a pharmacy making decisions on readers, inventory management and training, do you fully understand the magnitude and nuances that legal compliance will drive in your decisions? Are global serialization requirements taken into account?
- Do you have alignment with your upstream and downstream supply chain partners? What deadlines do your trading partners have in either supplying or receiving fully compliant product? Do your trading partner's legal interpretations of pedigree and serialization regulations conform to yours or will conflict arise? Has the necessary interoperability across all of your trading partners been factored into your full compliance timeline?
As one mid-sized manufacturer already implementing a full compliance plan stated with respect to the California extension decision, "California now gives us a chance to do four years of work in two years."
Getting Started
With a need to ensure compliant products (serialized products matched to serialized product pedigrees) coming off production lines and flowing into distribution potentially as early as 2009, time is of the essence when it comes to getting started on a full compliance plan.
Companies who have already started on pedigree solutions or serialization pilots should check to ensure that their compliance program is designed to deliver on all of the internal and external milestones necessary to meet the California date.
For companies not yet started and those just beginning, the ability to achieve full compliance for you and your trading partners may already be in jeopardy. Certain steps are immediately recommended:
- Gather together your cross-functional team, with required senior executive support, and address the hard strategic, technical, and operational questions to ensure your current plan is comprehensive
- Build an actionable full compliance roadmap for your enterprise that can ensure serialized pedigrees and unit-serialized products can be sent and/or received within trading partner deadlines
- Engage your trading partner network to synchronize your compliance plan with theirs and clearly outline interoperability test windows
SupplyScape Can Help
At every point along the full compliance path, from initial discovery and strategy development to serialization and pedigree solution creation and deployment, SupplyScape can help ensure success.
Strategy Consulting
The SupplyScape Strategic Consulting team partners with companies to help them analyze key business and regulatory questions and build actionable plans for full compliance in the United States and worldwide. Strategy Consulting is led by industry experts who leverage deep field experience in pharmaceutical industry, supply chain strategy and operations, RFID and serialization technologies, and most importantly, proven approaches to leverage technology investments for business value.
Global pharmaceutical companies and their trading partners have engaged our consultants to:
- Develop business strategies for global compliance
- Conduct product portfolio risk assessments
- Quantify business value potential from compliance investments
- Create serialization management blueprints
- Develop actionable serialization and pedigree project plans
Pedigree and Serialization Solutions
SupplyScape's Nexus provides a foundation of core shared services, event management, and serialized pedigree data. Nexus helps connect users to their operations and companies to their trading partners, accelerating the connectivity of trading partners for serialization and pedigree data exchange. Integrated with enterprise systems, Nexus enhances the ability to act upon rich serialization and pedigree data while collaboratively executing on shared business processes.
SupplyScape's Product Security solutions provide the full compliance foundation for serialization and pedigree requirements.
- E-Pedigree - E-Pedigree provides an integrated pedigree data management system for serialized and non-serialized products. Leveraging a nationally regulatory compliant and EPCglobal-certified ePedigree base, E-Pedigree supports existing production and distribution processes, protects IT system investments from SAP and others, and accelerates connectivity to trading partners.
- RxAuthentication - RxAuthentication enables companies to leverage serialized product information, including product location and EPC status, through a secure EPC repository and integrated portal. Triggered by events within the enterprise and throughout the supply chain, RxAuthentication delivers visibility into case and item-level identification for products tagged with either barcodes or RFID sensors.
Serialized Product Management Solutions (California Express)
Technology leaders Acsis, Hewlett-Packard, Nosco, Inc., SupplyScape, Systech International, and VeriSign have teamed up to create the California Express Solution - a comprehensive global solution for Serialization and ePedigree requirements.
The California Express Solution provides all the EPCglobal industry-standard components needed to:
- Build a complete strategy and implementation plan for serialization and ePedigree
- Define serial number management and carrier plans
- Integrate 2D Data Matrix and/or RFID technologies into labels and packaging
- Address changes to manufacturing, packaging lines and printed packaging components (labels, folding cartons, RFID, 2D, and line control)
- Implement electronic pedigree data management system
- Integrate with serialized product infrastructures like SAP Auto-ID Enterprise (AIE)
To get more information or to schedule a conversation with the SupplyScape Strategy Consulting team or one of our product solution specialists, please call 1-781-305-8085 or email sales@supplyscape.com.
