Manufacturers must be able to depend on their Contract Manufacturers (CMOs) and their Contract Packagers (CPOs) to meet current and upcoming serialization and traceability regulations. CMOs/CPOs with a serialization strategy that support their customers’ requirements will be well poised for this explosive growth.
Full-fledged, unit-level serialization requirements are already established and expanding in China, South Korea, Brazil (ANVISA), and the United States (DSCSA) among other nations. By 2017, these four countries alone will be responsible for 52% of global pharmaceutical sales [1]. As dozens of other countries work to finalize their requirements, CMOs and CPOs with international clients would be wise to prepare now.
Serialization implementation positions CMOs/CPOs to play an increasingly important role in supply chain management. As a leader in the pharmaceutical serialization market, Frequentz can help you quickly prepare to provide a range of valuable services in this competitive industry. Ask us how we have already successfully partnered with several CMOs/CPOs to develop their implementations.
IRIS (Information Repository & Intelligence Server) is Frequentz’s EPCIS, standards-based serialization, traceability, and verification platform. Built by Frequentz to adhere to GS1 standards, and launched in 2007, IRIS’s unit-level serialization solution is the most advanced, ERP-agnostic software on the market. IRIS serves as the serialization and traceability solution for:
- The largest global CMO
- Many regional-centric CMOs/CPOs
- Several of the world’s largest pharmaceutical manufacturers
- 67% of the pharmaceutical distribution market in the United States
Through our centralized Serial Number Management and EPCIS event repository, IRIS provides the flexibility that enables CMOs/CPOs to manage each customer’s unique brand requirements, while ensuring and maintaining global compliance. IRIS platform capabilities include the ability to:
- Generate serial numbers, or import and appropriately allocate them from the customer’s serialization-management solution.
- Capture and store all serialization and/or aggregation data sent from both production line and plant level systems.
- Validate data according to each brand owner’s business rules; provide monitoring; and send alerts in the event of any system failure or breach.
IRIS is a validation-ready hosted solution that is deployable through a private cloud to reduce IT resource consumption, operate cost-effectively, and enable rapid deployment. Our deployment options ensure the privacy and security of valuable business data.
Frequentz provides an out-of-the-box solution that is immediately prepared to meet inidividual country reporting requirements whether following GS1 Standards or other unique requirements. Our Trading Partner Network allows for immediate trading partner connectivity and ensures the interoperability and exchange of serialized event data. Frequentz is dedicated to our clients, many of which are recognized as global leaders in serialization. Serialization in the global pharmaceutical industry is no longer just a value-added benefit but an imminent need. Frequentz looks forward to serving more CMOs and CPOs and stands ready to assist you in your serialization plans.
[1] IMS Health, “The Global Use of Medicines: Outlook through 2017.” November 2013.
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