Five Challenges of Serialization in Pharmaceutical Supply Chains

Five Challenges of Serialization in Pharmaceutical Supply Chains How global pharmaceutical manufacturers, distributors and retailers are meeting these challenges with ROC IT Solutions Summary Pharmaceutical companies must begin planning now to meet legislative mandates for item-level serialization. Many governments are extending compliance deadlines, but leading companies are starting implementations now taking advantage of the extra time to systematically test, roll out and prove their systems and processes prior to the deadlines. The best companies are also working to ensure that the track and trace solutions they implement will deliver business benefits beyond regulatory compliance. Implementing serialization will require significant process changes as well as new technology. It has the potential to significantly disrupt what have become highly-optimized operations for pharmaceutical organizations. In this white paper we identify five key challenges of introducing item-level serialization in the pharmaceutical supply chain, and how ROC IT Solutions has helped leading companies meet these challenges. Contents Situation... 2 Legislative mandates... 2 Benefits beyond compliance... 2 Implementing Serialization... 2 The five challenges of implementing serialization... 3 1. Bottlenecks... 3 2. Scalability... 3 3. Network performance... 4 4. Time to deploy... 4 5. Ongoing costs... 4 Meeting the five challenges... 4 ROC IT Track and Trace: Serialization Solution... 6 Who we help... 8 Pharmaceutical and biotech manufacturers... 8 Wholesalers and distributors... 8 Retail pharmacies... 8 Hospitals and other patient care centers... 8

Situation Legislative mandates The rise in drug counterfeiting and diversion, and the attendant negative publicity, is leading dozens of state and federal governments to enact legislation requiring item-level serialization and the creation and maintenance of pedigrees (carrying drug-related and chain of custody information) for dangerous or high-consequence drugs. This legislation poses a huge challenge and significant cost to organizations that manufacture, distribute, and sell these drugs as they seek to comply with the mandates. In 2013 the US Drug Quality and Security Act (DQSA) superseded prior US state legislation. This act fundamentally changes the pharma supply chain by mandating serialization. Governments, industry organizations, and the courts have worked together to extend legislation deadlines to allow organizations enough time to comply in an effective manner: developing processes to accommodate serialization, implementing appropriate technical solutions, and collaborating with partners on integration and standards. Given the extended time period for compliance, organizations now have the opportunity to be more thoughtful in their approach. Many leading pharmaceutical companies, third party manufacturers, repackagers and distributors are getting started now to make sure they have processes and systems that are tested, rolled out in a systematic way, and proven over a period of time prior to legislative deadlines. Benefits beyond compliance The best companies are demanding solutions that will not only satisfy legislative mandates, but also help them achieve business benefits beyond compliance. These benefits come from the tighter product control that serialization provides. They include: Better product authentication and integrity, ultimately protecting and enhancing the company s brands and shareholder value. Greater revenue share by reducing the gray market activity that occurs when products are counterfeited and diverted. Better control over and visibility into the supply chains, leading to more accurate shipments. Fast and efficient reverse logistics or recall processes. In countries with single-payer or other centralized health care systems, companies reap additional benefits through improved ability to recoup payment from centralized government agencies that reimburse patients drug costs. Implementing Serialization Pharmaceutical manufacturers, distributors, and retailers are undergoing a multi-phased, multi-year process to implement item-level serialization in a way that protects them and ROC IT Solutions 2

enables them to reap the greatest rewards. This process will likely entail the following phases: Strategic planning Process and solution design Pilot implementation and testing Full implementation Partner integration and alignment Technologies and implementation services can be grouped into four primary classifications: Serialization Solutions to create, verify and apply serialized labels to product and perform initial aggregation. Solutions include Optel Visions TrackSafe. Serial Number Management Solutions to manage and maintain serial number status, ranges, hierarchies and aggregations. Solutions include TraceLink, Oracle s OPSM, Axway, rfxcel and Frequentz. Event Management Solutions to allow track and trace events to be stored and harnessed for business and compliance benefit. Event Data Capture Solutions to facilitate capture of all serialized events from the end of the line all the way through the supply chains. Solutions include ROC IT EdgeTRAC. All of these technologies require integration services to tie them into existing IT infrastructures. IT services companies with practices specializing in track and trace include NTT Data, Terillium and CSC. Each technology decision results in a cascade of choices that follow. Companies must consider how these technologies and services will fit into their existing operations, such as packaging in a manufacturing facility, and how they will extend their core business applications, such as warehouse management or enterprise resource planning systems, in which they ve already made significant investments. The five challenges of implementing serialization These process changes and the introduction of new technology have the potential to cause significant disruption to highly-optimized operations for pharmaceutical organizations. Following are five significant operational problems caused by introducing item-level serialization: 1. Bottlenecks Serialization is likely to create new operational bottlenecks in the physical supply chain. These include bottlenecks from performing item-level serialization tasks, as well as bottlenecks from having to manage and interact with serialization solutions. 2. Scalability Serialization solutions must be scalable to support distributed operations across a manufacturing facility, distribution center, warehouse, and dispersed geographies. This is a major challenge. ROC IT Solutions 3

3. Network performance Reduced network and system performance can result when centralized serialization computing solutions are implemented to address a distributed problem. 4. Time to deploy Long implementation cycles for serialization solutions extend the disruption to the company s operations and delay the benefits of serialization. 5. Ongoing costs Serialization solutions have potential to add yet another ongoing maintenance cost to companies already-stretched IT departments. Organizations are applying both process and technology changes to meet these challenges. They need an appropriately-architected solution to suit the distributed nature of their operations to facilitate the many disparate actions that are happening at once in an operations center. Meeting the Five Challenges To meet these five challenges, pharmaceutical organizations require highly scalable, cost-effective, and easy-to-manage solutions that fit their distributed environments. They should not have to retrofit their already-optimized operational processes to fit a monolithic IT system. At ROC IT Solutions we understand this. We have built our solutions on a distributed architecture that fits into and scales across our customers operations. With distributed edge processing and a modular approach to business logic delivery, we help pharmaceutical operations address the challenges of serialization in the following ways: 1. Avoiding bottlenecks The distributed nature of the ROC IT EdgeTRAC software solution, using "intelligent edge" data capture and real-time decision processing, enables decisions to be made and instructions to be delivered rapidly to the edge-of-the-network locations where work is performed. This keeps intensive computing contained at the edge, and keeps goods flowing through the points of the system. For example, rather than having an operator open cases in a receiving area to check individual items, ROC IT EdgeTRAC software allows for configuration parameters to limit the number of cases to be scanned, and utilize inference for the closed cases so that all items do not need to be scanned and verified. It automatically records the information, communicates it to the right systems, and provides instructions to the operator. ROC IT EdgeTRAC software enables all system processing including plan data queries and business logic processes to occur at the point of automation. Therefore only meaningful events such as the completion of a valid transaction would be sent upstream to core applications. This means better IT systems availability, fewer disruptions, and lower IT cost. ROC IT Solutions 4

ROC IT Solutions combination of edge intelligence and processing helps customers reduce or eliminate the bottlenecks that item-level serialization can introduce into their operations. 2. Assuring scalability ROC IT Solutions creates edge data capture solutions that are highly scalable and remain manageable even as they grow to span thousands of unique, independentlyrunning processes. Unlike traditional, monolithic computing systems, ROC IT Solutions systems scale out in a horizontal fashion, handling many disparate and Edge Devices are commercially available smart computing devices that perform automated data capture. Deployed at key operational points where goods pass through a facility, they integrate with other devices such as printers, perform processing locally, and take actions such as real-time alerting of operators. diverse points of automation. This enables the right process to occur at the right place, and allows many different processes to occur at once. It enables organizations to increase the many processes they perform in their operations facilities. For example, an organization can have an Edge Device performing receiving operations, another inside a quarantine area providing operators with next steps, and a third with a printer attached for creating barcode labels on-the-fly for non-serialized items. The system s architecture and robust capabilities enable these diverse operations across a large and highly distributed supply chain. It scales easily from a few devices to a many dozens of devices. 3. Maintaining network performance By distributing business logic and processing to the edges of the network, ROC IT solutions dramatically reduce the need for constant communication with centrallylocated applications and data stores. 4. Managing the time to deploy Unlike solutions requiring custom development, costly integration services, and manual ongoing maintenance, ROC IT solutions are delivered as a set of pre-defined functional modules (i.e rework, receiving, shipment), and an array of form factors that fit into and support our customers operations. These elements enable rapid solution deployment and allow our customers to spend their service dollars on higher-value activities than nuts-and-bolts implementation and integration. 5. Managing ongoing costs Centralized administration, along with the ability to centrally deliver and reconfigure functionality at the edge, make for efficient ongoing maintenance. Administrators can add new or reconfigure existing Edge Devices individually or in groups, temporarily disable parts of the network, and add or change integration touch-points quickly and from one central point. ROC IT Solutions 5

ROC IT EdgeTRAC Software Solution for Serialization The ROC IT EdgeTRAC software solution enables widespread local automation with centralized control and visibility. It enables our pharmaceutical customers to perform item-level serialization in an efficient and cost-effective way, while laying the groundwork for them to achieve ROI-based objectives such as improving the accuracy of their supply chains. ROC IT EdgeTRAC software makes contextual plan data and business policy information available at the edge of our customers operations, enabling them to make decisions and take actions where the work is done not just in a manufacturing facility, distribution center, warehouse, or retail center, but in specific work areas such as in a receiving area, in quarantine, at a pick-and-pack station, or in a cold store. Our solution enables processing to occur at each point, independently from the other points. This approach avoids the burden on the network and core business applications that a monolithic computing approach would create. ROC IT Solutions provides a framework to manage and enrich information at each step of the process. Due to the added complexity that serialization introduces in a system, there is need for an infrastructure layer that senses each business step as it occurs in the operation and guides operators about what actions to take. In addition to assisting decision-making at the physical layer, ROC IT Track and Trace enables and optimizes the information layer. This includes creating the necessary EPC events for an EPCIS or pedigree application, and authenticating electronic pedigrees in real time for receiving, shipping or any other intermediary step in which a product s chain of custody needs to be maintained. ROC IT Track and Trace Solution ROC IT EdgeTRAC software bridges the gap between the physical world and core business applications. The physical world includes RFID equipment, 2-D and linear bar code readers, displays and printers. Business applications benefit from standards-based, two-way data integration. These include EPCIS and pedigree applications (Axway, IBM, rfxcel, and TraceLink), warehouse management systems (Manhattan Associates and Red Prairie) and ERP applications (SAP, Oracle, legacy systems). Components of ROC IT EdgeTRAC Software ROC IT EdgeTRAC software sits at distributed locations in the physical and IT value chain to enable edge processing and back-end integration. Edge Devices include hand-held scanners, printers, dock portals and similar hardware. They are located where work is performed: for example, at a rework station. Edge Devices perform data capture and real-time alerting back the operator. They also contain centrally-managed, automatically-delivered data and ROC IT Solutions 6

business logic that enable them to perform specific functions in real time, such as matching incoming reader data to an inbound RxASN or pedigree, determining what steps to perform based on rules, taking an action such as sounding an alarm, and providing instructions to the operator via a user interface. The Control Tier for each operations center can be located on a physical server or a VM slice, a laptop or tablet, or even the cloud: anything with a proper OS, browser and network connection. The Control Tier manages the two-way data integration that must occur for Edge Devices to do their job, and for back-end systems to receive information confirming that work has been done. It receives plan data such as RxASN, serial numbers and EPCIS data. It delivers the right plan data and business logic to each Edge Device based on context such as location of the Edge Device and the processes it is intended to perform. The Control Tier receives upstream data from the Edge Devices and delivers the data (typically confirmation of a valid transaction) back to core business applications. While the devices work together, they are not interdependent, meaning that they neither rely on each other for processes to occur nor do they represent a single point of failure. Edge Devices work independently from each other 1, and while they exchange information with the Control Tier, they can perform their function without connection to it. This enables time-critical operations to continue even if the IT network experiences downtime. Distributed business logic ROC IT EdgeTRAC software is designed for centralized management of a distributed system. Functional modules encapsulate the various processes at the edge, including receiving, label printing, picking and packing, shipping, aggregation, special handling, quality assurance/audit, returns and destruction. Because we develop functional modules as discrete processes that can fit modularly into our customers unique operations, the modules are able to support those operations by capturing each customer s best practices, local knowledge, and uniqueness of their operation without having to write custom code. Integrated station deployment To make serialization easier for our customers, ROC IT Solutions delivers EdgeTRAC software in a variety of form factors, or stations. Stations can be built into handheld computers, wearable terminals or tablets. Each station contains an Edge Device with the appropriate business logic, along with a wide variety of third-party data capture and feedback devices such as barcode scanners, photo eye sensors, touch screen displays, UIs, LEDs and light stacks. This ability to smoothly interact with operations is one key to improving process capabilities without impacting productivity. 1 Edge Devices can also be configured to have coordinated processes. ROC IT Solutions 7

Who We Help We help companies at all points in the pharmaceutical supply chain with the following types of serialization processes: Pharmaceutical and biotech manufacturers Serialization during packaging (by unit/case/pallet) Warehouse or distribution center operations for picking, packing, and shipping of serialized product Returns processing Wholesalers and distributors Receiving serialized product Picking serialized product Packing and shipping serialized product Returns processing of serialized product Receiving serialized product in independent pharmacies you serve RFID-enabled vendor managed inventory Retail pharmacies Receiving serialized product at distribution centers and/or retail pharmacies Returns processing of serialized product Hospitals and other patient care centers Receiving serialized product at in-patient pharmacies or central fill operations Returns processing of serialized product If you are experiencing the business challenges outlined in this paper, contact ROC IT to discuss how our unique distributed serialization solutions are helping global pharmaceutical companies to meet these challenges. ROC IT Solutions 1150 Pittsford-Victor Road, Pittsford, NY 14534 Phone (585) 641-0035 Sales@ROCITSolutions.com www.rocitsolutions.com ROC IT Solutions enables serialized receiving, shipping, returns, deactivation, aggregation and de-aggregation at all points in the supply chain, from manufacturers to wholesalers, distributors, and retailers. Through more accurate and efficient supply chain serialization, ROC IT Solutions helps companies protect revenues, combat counterfeiting and diversion, and ensure consumer safety. Our solutions allow companies to capture and process data for serialized assets at the edge of the supply chain, where materials handling takes place. By reducing data capture errors and providing real-time decision making at the point of materials handling, our solutions enable serialized product tracking without bottlenecks or bandwidth issues. Our unique distributed architecture enables agile and scalable solutions that are easily deployed and maintained to support any ERP, EPCIS, track-and-trace, Auto-ID or other application, as well as interoperability with any device for barcode and RFID data capture, using GS1 standards. Learn more at www.rocitsolutions.com. 10 June 2014 ROC IT Solutions 8