System Support for Track and Trace

One of the biggest challenges for manufacturers is maintaining track and trace from the point of manufacturer to the point of use using fragmented and manually intensive supply chain processes. Manufacturers can choose to outsource to OM HealthCare Logistics (Richmond, VA) to provide services that include the track and trace of product by serial number. The company has adopted RedPrairie Corp.’s (Waukesha, WI) Warehouse Management solution to direct operations over the company’s flagship third-party logistics distribution center.

OM HealthCare Logistics, which provides supply chain solutions for the medical device and life-sciences markets, is using the warehouse management system for medical device and pharmaceutical distribution and management. The company will also use the system for kitting and serialization track and trace for its clients in the future.

"As we started up our new third-party logistics division, we realized we needed a technology infrastructure that can support track and trace by lot and serial number from the point of manufacturer to the point of use," says Denise Odenkirk, vice president, OM HealthCare Logistics. "We selected the RedPrairie’s warehouse management system because it has been used in the electronics, food, and automotive industries to support track and trace for over two decades," Odenkirk says.

During the manufacturing process, medical device and pharmaceutical manufacturers track specific components and raw materials that are used during the manufacturing process via internal batch records.

Regulations go well beyond manufacturing to the point of use. This includes track and trace by lot and often serial number to the point of use. Manufacturers often struggle with maintaining compliance with FDA regulations within their supply chain because it is very complex and disparate. Manufacturers must ship product to hospitals, distributors, physicians, sales representatives, and often the patient’s home.

OM HealthCare Logistics has the ability to maintain track and trace data used for recall purposes in RedPrairie’s Warehouse Management System. In addition, the company has integrated the RedPrairie Warehouse Management System with rfXcel to store inbound and outbound pedigrees, share data downstream, authenticate product and provide the infrastructure to manage the communication of data between trading partners on behalf of clients.

"The system goes beyond the basics by providing track and trace at a component level for procedure kits, by enabling the capture of lot and serial number outbound and by easily interfacing with other systems," Odenkirk says. "It is not complicated because it is tried and true and functionality that exists out of the box."

OM HealthCare Logistics uses the solution to provide clinical supply samples as well as reverse logistics. RedPrairie’s Warehouse Management solution handles many of the tasks associated with those operations, along with functionality designed to enable compliance, recall management, and expiry date notification.

Among its services, Red Prairie provides transportation solutions that can track these products when they are on the road, Web-based tools to allow suppliers of the products to interact with software, and reverse logistics for returns of products as they come back in the supply chain.

According to Red Prairie’s Tom Kozenski, vice president for product strategy, tracking and identifying every item in a warehouse and then knowing where all those items were shipped can be a very cumbersome process and impossible without the right system in place. Red Prairie’s warehouse management system provides the necessary tools to track inventory issues including details, such as serial numbers, lot numbers, expiration dates for articles that can expire, country of origin of some parts.

"All of that can be accepted through an integration into our computers and then we track it down to the specific item in a specific box as it moves throughout our warehouse and to what customers it may go to," Kozenski says. "We can do it accurately and we can do it quickly without slowing down the operators in the facility."

During the manufacturing process, bar codes, which identify the lot, expiration date, and serial number are applied to finished goods. One challenge for pharmaceutical-medical device serialization is the association of parent child relationships, or units-cases, on pallets. It is an exhaustive effort that is difficult to do at the distribution speeds that the market demands.

In addition, there is no standard of technology for serialization. It can be done via bar code, 2-D bar code or radio frequency identification (RFID). There are still a lot of issues with RFID technology. The process of retrofitting lines for distributors that do not have serialization technology impacts manufacturers.

Overall, RedPrairie delivers productivity solutions to help companies in three categories — inventory, transportation, and workforce. The company provides these solutions to manufacturers, distributors, and retailers around the world looking to support business strategies for increasing revenue, reducing costs, and creating competitive advantage.

Red Prairie also has tools that help drug store retailers connect to supply chain signals. There is also a team that is experienced and educated in providing FDA certifications of software when they are implemented. This is due to the fact that there are governmental regulations about security, accuracy, and integrations of software of
customers.