TraceLink Inc., the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, today announced that it has released major enhancements to its Life Sciences Cloud platform. Customers using the Life Sciences Cloud to securely and efficiently meet emerging regulatory requirements across a range of geographies now have access to new serialization capabilities for multiple international markets, including Brazil and the European Union.

In addition, performance of Serialized Operations Manager in the Life Sciences Cloud has been improved dramatically by removing any impact to data processing speeds as serial number repositories grow in size, and achieving serial number read-time speeds that are 100 times faster than they were previously. Both of these enhancements enable TraceLink customers to perform a range of operational tasks in a fraction of the time they’ve become accustomed to when working with extremely large serial number volumes.

Prior to releasing these new software and platform capabilities to customers, TraceLink performed successful validation testing of every aspect of the Life Sciences Cloud, providing customers with documented certification of the installation qualification (IQ) and operational qualification (OQ) results, enabling customers to successfully execute their required performance qualification (PQ) tests.

“One of the most significant challenges facing global pharmaceutical companies is that there are no global standards for serialization, making it difficult to simultaneously meet compliance regulations in multiple countries,” said Shabbir Dahod, president and CEO of TraceLink. “The latest updates to the Life Sciences Cloud, however, enable our customers to meet a diverse set of international requirements at the same time. This is a critical requirement among pharmaceutical manufacturers that have selected TraceLink for global serialization in several regions, including eight that are currently working on their 2015 Phase One plans for Brazil. With more than a decade of experience in global regulatory legislation, TraceLink is able to deploy fully validated country-specific software modules faster than any other track and trace software provider.

“In addition, the data processing capabilities of the Life Sciences Cloud continue to deliver unmatched performance,” added Dahod. “Customers can now access serial numbers in Serialized Operations Manager 100 times faster than before, so a specific task performed for 1 million serial numbers that used take to over an hour to complete can now be executed less than 1 minute.”

Advancing the TraceLink Life Sciences Cloud: What’s New

To help global pharmaceutical manufacturers manage an increasingly diverse landscape of country-specific compliance requirements, TraceLink has updated its Life Sciences Cloud platform to deliver integrated workflows with third-party serialization systems, automated compliance triggering, and serial number creation and management tools that support both Brazil RDC 54 and the European Union’s Falsified Medicines Directive. The platform also now provides broader global support for master data management and a streamlined experience for US pharmacies, hospitals, physicians, and long-term care facilities that have a deadline under the Drug Supply Chain Security Act (DSCSA) on July 1, 2015. Some of the specific enhancements include:

• Advanced EPCIS Integration with enterprise serialization management systems—for synchronizing enterprise EPCIS events with TraceLink to leverage automatic compliance triggering and workflow management of TraceLink’s Serialized Operations Manager module;

• Enhanced serial number replenishment from external serialization management systems—to automatically replenish serial numbers through a single interface in synchronous or asynchronous formats, which streamlines the process of providing serial numbers to contract manufacturing organizations (CMOs) that have diverse systems and preferences;

• Native Brazil RDC 54 serialization support—for creating and managing serial numbers for Brazil RDC 54 compliance;

• Support for the Falsified Medicines Directive in the European Union—for creating and managing both EU GTIN and NTIN serial number templates;

• Comprehensive master data support—to ensure global support for master data management across a broader range of regions that now include the United States, the European Union, Brazil, China, South Korea, Turkey and more; and,

• A simplified Product Track user interface specifically for US dispensers—that provides an easy conversion of paper-to-electronic Transaction Histories for purposes of meeting the July 1, 2015 DSCSA deadline for receiving and archiving compliance documentation.

To learn more about the Life Sciences Cloud and how to build a flexible, cost-effective global serialization, track and trace, and reporting platform, visit www.tracelink.com.