E-Pedigree Technology & Standards

Forward-Thinking Technology

SupplyScape E-Pedigree is an enterprise business process application developed to deliver world class performance, scalability, and interoperability by leveraging leading-edge technology combined with SaaS platform accessibility and software architecture designed specifically for the unique needs of the Life Sciences industry.

The E-Pedigree solution is a Java/J2EE based multi-tier architecture built for scale, performance, and interoperability. SupplyScape's patent-pending Semantic Reduction™ technology for data compression is used to reduce hardware footprint while at the same time increase overall system performance. As operational process needs vary widely, and may change over time, the E-Pedigree solution was designed to mix synchronous or asynchronous modes to reduce operational overhead yet provide immediate response when required. As data security is paramount, E-Pedigree also uses a broad range of information security technologies such as X.509 certificates, FIPS 186.2 digital signatures, and FIPS 140-2 cryptographic capabilities.

E-Pedigree leverages the extensive integration services provided by the SupplyScape Nexus foundation to integrate to a broad range of enterprise software systems such as ERP, WMS, and serialization systems. A company with significant technological capabilities can integrate to enterprise business systems by using XML and EPCIS events to leverage solutions such as SAP NetWeaver platform (XI), Auto-ID Infrastructure (AII), and Object Event Repository (OER). For businesses with more modest infrastructures, full capability is still available via flat file integration and through manual user interfaces.

E-Pedigree also leverages the broad trading partner connectivity services of Nexus to help companies tightly connect or loosely couple inter-company business processes together. Existing B2B gateways can be leveraged by E-Pedigree to share pedigree data with trading partners. As EPCIS-interfaced systems become commonly adopted, companies will be able to leverage these advanced EPCIS interfaces to send and receive pedigree information. Finally, for companies who have customers with limited technology infrastructures, full E-Pedigree functionality can be provided to trading partners via the browser-based Nexus Portal.

E-Pedigree improves business responsiveness and organizational interoperability by sharing operational events with other business systems using the Nexus Event Management system built on Web Services. This provides proactive visibility to unanticipated events throughout an organization, allowing groups such as Customer Service to be notified of important issues that require attention.

Built-in Standards Support for Global Businesses

SupplyScape embraces industry standards so that our customers are able to protect and enhance their enterprise software investments as emerging solutions in EPCIS, global serialization, and RFID become broadly adopted. Where existing standards do not fully cover business needs, such as in the case of global serialization, SupplyScape invests in new technology approaches and works closely with standards bodies to advance adoption of new solutions.

SupplyScape is leading the industry in the adoption of GS1 EPCglobal standards to ensure electronic pedigree interoperability, as well as the application of Electronic Product Code (EPC) standards for serialized pallets, cases, and item-level products. Because all elements of the software adhere to the GS1 EPCglobal standards, all supply chain participants can quickly and cost-effectively add E-Pedigree to their current supply chain infrastructure and processes, helping streamline operations and secure the prescription drug delivery chain from counterfeits and diversion.

E-Pedigree supports and is certified to the GS1 EPCglobal Drug Pedigee Messaging Standard (EPCglobal DPMS). We actively participate in all phases of standards development and in standards compliance forums to ensure that our software complies with the GS1 EPCglobal standards.

SupplyScape experts contributed essential concepts including the universal e-pedigree format, the pedigree envelope, the self-authenticating pedigree, and the global serialization approach now being adopted by the Pharma industry. Read more about just one of the industry initiatives that SupplyScape is involved in through the GS1 EPCglobal Healthcare Life Science Business Action Group (EPCglobal HLS BAG)

Compliance with Current and Future Pedigree Regulations

SupplyScape defined the industry's universal electronic pedigree approach for serialized and non-serialized product. This approach became the foundation for the current, broadly adopted EPCglobal Drug Pedigree Messaging Standard which complies with the pedigree format and rules in all states (including California, Florida, and Nevada) and meets the requirements of the federal Prescription Drug Marketing Act (PDMA). SupplyScape E-Pedigree fully implements the regulatory and interoperability richness provided by the EPCglobal DMPS.

When the system was originally designed, E-Pedigree was architected to help companies optimize their handling of and compliance for both serialized and non-serialized product lines. Thus, companies today managing primarily non-serialized products can rest assured that they are protected from unnecessary upgrades or process reengineering due to a more limited design as global item-level serialization takes hold. The solution was also designed as a potential model to accommodate international chain of custody tracking which may develop as part of global serialization efforts.

To maintain an in-depth understanding of regulatory requirements, SupplyScape continually consults with our customers through one-on-one meetings and collaborative groups such as the SupplyScape Customer Council. In addition, SupplyScape engages with state and federal regulators, works with leading industry groups / organizations such as PhRMA, HDMA, and NACDS, and solicits feedback from our industry partners such as SAP and HP.

SupplyScape's extensive research of the laws and regulations enables us to thoroughly understand their potential impacts on the operations of the Bio/Pharma companies, wholesalers/distributors, pharmacies/hospitals, third party logistics providers and returns service providers. We infuse this regulatory insight into our products. The pedigree format, business rules, integration capabilities, and user interface facilities of E-Pedigree and the Nexus foundation are all designed based on this extensive knowledge.