Pharmaceutical Track and Trace solution from IBM

The goal

Protect your supply chain, protect your brand

From manufacture to point of sale, products in the pharmaceutical supply chain can change hands up to ten times—with each transaction prone to risk or diversion. Loss of product to theft and fraud, replacement costs for product recalls and supply chain inefficiencies can erode profits and brand value. The Pharmaceutical Track and Trace solution from IBM helps companies reduce these risks and improve patient safety and operational performance.

The advantage

Automate your supply chain. Protect your patients.

Manual pedigree and other supply chain tracking procedures are time-consuming, prone to human error and often have no interface to your management reporting systems or your trading partners’ business support systems. Enter the Pharmaceutical Track and Trace solution from IBM.

Sensor-based technologies such as 2D barcodes or radio frequency identification (RFID) tags attached to products at the unit, case or pallet level enable the capture, tracking and tracing of custodial information of products between the manufacturer, wholesaler and the retail pharmacy or hospital. Both 2D barcodes and RFID tags can be linked back to far more descriptive product information such as NDC number, dosage and strength information, lot number, manufacture and expiration dates. Sensor-based technology can also record transaction-based information such as identification of commercial purchasers, invoice data, transfers between packaging facilities and authenticated release to approved product distributors. Improved and immediate visibility of your products helps you make informed decisions quickly and cost-efficiently.

The benefits

Beyond compliance

Regulatory agencies are increasingly recommending or even mandating compliance with supply chain monitoring and security. The use of sensor-based technologies such as 2D barcodes and RFID are key components of a secure end-to-end drug authentication or electronic pedigree program. In addition, an automated supply chain can help you build sales volume by controlling inventory shrinkage and improving product forecasting. Operating costs are reduced when automated supply chains improve inventory accuracy and management, streamline pick and pack operations and alert logistics teams to returns due to expiration dates.

Most importantly, the Pharmaceutical Track and Trace solution from IBM is a robust, extensible platform for data capture and delivery from a broad set of devices and provides a complex event processing rules engine to turn the data into actionable events and insights. The platform capabilities also include reporting, analytics alerts and notifications as well as business dashboards that act on product movement information to help companies transform business processes. It can be integrated with other operational systems to help protect and improve market share by reducing product diversion, improving the effectiveness of product recall management, enhancing patient safety and increasing consumer confidence in your products.

Asset tracking features can improve utilization and availability of manufacturing equipment by tracking movable tools and other assets according to their physical location.

The goal

A secure and reliable supply chain

An agile and efficient supply chain is necessary to differentiate your brand, improve consumer safety and reduce inventory costs. Regulations, counterfeiting, diversions and trading partner requirements are also driving the need for improved visibility into the supply chain. With the Pharmaceutical Track and Trace solution from IBM, you can quickly detect issues and take fast and effective action to make the most of new market opportunities.

The advantage

Why IBM?

IBM has leading pharmaceutical industry expertise and our IT and business consultants have provided support to 75% of the top 40 major pharmaceutical manufacturers with 750+ pharmaceutical engagements in the last 7 years.

IBM is also a leader in pharmaceutical track and trace expertise. Through a proven, scalable Pharmaceutical Track and Trace solution, IBM offers pharmaceutical companies a low risk approach to secure and automate their supply chains—an approach already selected by major manufacturers and wholesalers. In addition, this solution has been certified by EPCglobal under Drug Messaging and EPCIS Standards.

IBM's unique combination of capabilities include experienced services teams, software and partners—such as sensor or barcode infrastructure partners—and can help chart out and implement a path toward regulatory compliance and improved supply chain efficiency.

The benefits

Efficient, authenticated distribution

Do you know where your products are? How long they have been in the supply chain? The Pharmaceutical Track and Trace solution from IBM can help you answer these questions and more. Clear product visibility allows you to effectively and cost-efficiently authenticate drugs, manage targeted recall, resolve chargebacks, manage product expirations and improve forecasting and planning.

Using sensor-based technology to build electronic data capture and reporting into your supply and distribution chain provides benefits from the production line to the front office to the pharmacy or hospital. With production line operational reporting, real-time results of unit, case and pallet movement can be monitored at each node in the supply chain. This information can be fed into a data warehouse and ERP systems to monitor shipments, supplier receipts and authenticate product transfers, providing near real-time management views of product movement.

This solution can help your company:

• Continue to grow revenues by improving product availability and ensuring product quality to meet patient and government expectations.
• Dramatically reduce inefficiencies throughout the supply chain (e.g. charge backs, recalls).
• Reduce the product counterfeiting and diversion by mass serialization and unit tracking.
• Meet existing and future global regulations and mandates.
• Transform your ability to track and trace products by integrating visibility from manufacturer to wholesalers to distributors to pharmacies and hospitals.
• Strengthen their relationships with key trading partners.

The approach

Global Standards compliance establishes a foundation for interoperability

The Pharmaceutical Track and Trace solution from IBM adheres to global standards, such as GS1 and EPCglobal, which provides interoperability with your trading partners.

The GS1 System is an integrated system of global standards that provides for accurate identification and communication of information regarding products, assets, services and locations. It is the most implemented supply chain standards system in the world. GS1 includes standards for bar-codes and also includes EPCglobal, which is a new global standards system for radio frequency identification (RFID) technology.

The financial advantage

Improve the value of your brand

With the Pharmaceutical Track and Trace solution from IBM, we can help you:

• Preserve brand reputation and customer confidence.
• Protect your investment in drug discovery by reducing counterfeiting.
• Build sales volume by controlling "shrinkage" and improving product forecasting.
• Reduce the risk of diversion and theft by streamlining logistics.
• Reduce the cost of product recalls.
• Lower operational costs through automation and improved efficiency.

Next steps

Questions about this solution? Contact an IBM sensors and actuators specialist.

The issues

GS1 and EPCglobal: establishing data sharing standards

Tracking custody changes of pharmaceuticals through an increasingly complex supply and distribution chain is now facilitated by both 2D barcode and radio frequency identification (RFID) technologies. GS1 and EPC Global define a set of standards which transforms 2D barcode and RFID sensor data into business information that can be used across your entire enterprise to make more effective business decisions. A robust enterprise class electronic product code information system (EPCIS) helps you to manage and share supply chain information in a highly secure environment.

The benchmark

A leader in evolving standards

The Pharmaceutical Track and Trace solution from IBM is based on tightly integrated elements of the IBM WebSphere® and IBM InfoSphere® software platforms and supports major industry standards for data capture and information sharing and hardware components such as tags and readers.

• IBM participated as a founding member of Auto-ID, Inc. and is currently a member of the subsequent RFID standards body, EPCglobal. We have also worked with the U.S. Food and Drug Administration in exploring standards for securing the pharmaceutical supply chain.
• In 2004, IBM created the sensors and actuators solutions business unit, dedicated to developing on demand capabilities for businesses that make and distribute physical products.
• We continue to expand our solutions portfolio to address industry concerns for supply chain security, regulatory compliance and critical asset tracking.

The components

Configurable parameters. Customized extensions for EPCIS.

IBM will work with you to deliver a track and trace solution that supports your needs today and scales for the future. Your solution may include:

• IBM WebSphere Premises Server?a robust, extensible J2EE application platform delivering a flexible architecture for sensor data capture from a broad set of sensor-based devices. It also provides filtering and aggregation of data as well as a complex event processing rules engine to turn the data into actionable events or insights for integration into your business processes.
• IBM InfoSphere Traceability Server?a central data repository for data sharing, reporting, analytics, alerts and notifications that act on product movement information to help companies transform business processes. The InfoSphere Traceability Server is a certified implementation of the EPCglobal EPCIS standard to ensure complete interoperability with enterprise and trading partner applications. It provides air-tight security options to reduce risk and increase the trust in product movement information. In addition, it provides an integrated pedigree application that supports multiple compliance models and simplifies implementations for pedigree mandates.
• IBM integration and IT services—IBM assists clients in the development of an implementation strategy and/or program management and implementation support for the rollout of sensor-based solutions scaling from pilot to enterprise-wide implementations.
• IBM System x® platform servers and IBM InfoPrint® 6700 R40—a thermal RFID printer enabling the printing of RFID tags.
• Third party tags, transceivers and RFID or 2D barcode readers.

The implementation

Full speed ahead

A major global pharmaceutical manufacturer turned to IBM to design and implement a pilot program to track one of the world's most susceptible drugs to counterfeiting and diversion. This multiphase project included in-line tagging of pallet, case and individual items on a single production line, and capturing production and expiration data from the SAP manufacturing execution system.

This project was then extended to the manufacturer's distribution center, integrated with their warehouse management system, and connected with the EPC network. With operations functioning at full-line speeds, the project resulted in successful product label integration and read reliability.

The cost of ownership

Built to work. Built to last.

The Pharmaceutical Track and Trace solution from IBM can help you build a cost-effective platform that is:

• Compatible with most 2D barcode and RFID standards and complementary for coexistence of current and new technology including barcodes and RFID tags.
• Built on common middleware for supply chain, asset tracking and production and facility operations, allowing connectivity with business applications.
• Built on a standards-based and extensible technology platform that helps protect your previous IT investments.

Next steps

Questions about this solution? Contact an IBM sensors and actuators specialist.