Managing Automation - June 2008 - (Page 49)

and participate in the process. “It’s expensive to put the infrastructure in place to support all this traceability,” says Jim Sabogal, vice president of the PHARMA’S NEXT CHALLENGE global industry business unit New e-pedigree and serialization mandates are prompting pharmaceutical makers to refor life sciences at SAP AG. evaluate their supply chains and invest in new Beyond the cost factor, the technologies. existing technology has limitations. On the hardware side, STEP 1: Led by California and Florida, the an ongoing debate over the e-pedigree mandates require drug makers to maintain auditable electronic records of the merits of bar code vs. RFID “chain of custody” of a drug as it moves through technology is slowing down the supply chain, from the factory to the final the process of creating induspoint of sale. try track-and-trace standards. STEP 2: California is looking to go one step On the software side, most enfurther with serialization, which requires manuterprise software platforms, infacturers to maintain a unique serial number for cluding popular ERP packeach unit within a specific production run. Today, drug makers typically assign a serial numages, lack the ability to ber to everything within a specific production serialize and track pharmarun or to an individual lot or pallet. The probceutical product information lem is that most enterprise ERP and SCM appliat the lowest level — for excations are currently not suited to handle the ample, an individual pill or botexponential amount of data that will be required to track each item sold. tle instead of tracking at the lot or pallet level. “When every bottle has a unique serial number with its life history, you’re talking about tracking more fine-grained information and doing it at an item level,” says Peter Spellman, senior vice president of sales and software-as-a-service at SupplyScape, a provider of e-pedigree applications. “Existing SCM and ERP systems are not designed to work that way.” SAP and other enterprise software providers, including CDC Software/Ross Enterprise, are working with customers to address those capabilities. For example, SAP’s Auto-ID Infrastructure uses RFID technology to facilitate the capture of serialized data from devices at local sites while providing business context to turn that data into meaningful business events. SAP’s Object Event Repository serves as the cenThe California e-pedigree program was tralized system of record for tracking the extended by two years in March, in part, serialized objects. In addition to the ERP providers, best-ofto give the industry more time to devel- breed companies, such as SupplyScape and op track-and-trace standards. Acsis Inc., are providing vertical capabilities in the areas of e-pedigree and pharmaceutigies are essential for storing and accessing critical cal-specific track-and-trace functionality. details about the product, including where it was “If you set up a production run in a manufacmanufactured, what its ingredients are, and where turing facility today, you have an eight-hour shift the ingredients originated. making the same product and you put the same Given the global nature of the pharmaceutical identifier on any of the products that are prosupply chain, it’s not enough for companies to duced that day,” says Stuart McCutcheon, CEO invest in the technology for their own manufacof Acsis, which offers the PharmaTrak serialturing facilities; they also need to ensure that ized distribution application, which works with their networks of suppliers make the investment SAP. “We take serialization to the next level aged goods and automotive, have been able to use or identify the supply chain as a strategic weapon in their organizations to create joint value with different trading partners, the supply chain has historically been a stepchild within life sciences,” says Hussain Mooraj, research director of healthcare and life sciences at AMR Research Inc. “When faced with a recall situation, companies first have to figure out where all their product is, and that’s a bear of a job because of the fragmented nature of the healthcare value chain.” This laissez-faire attitude toward supply chain best practices will very likely change soon. Pending regulations in California and Florida are putting pressure on pharmaceutical makers to revamp their supply chain practices as part of a mounting effort to curtail drug counterfeiting. The initiatives, known as electronic pedigree (e-pedigree), require manufacturers to track individual units of pills and other medications from the time they leave the factor y floor to when they actually land in an individual patient’s prescription package. The high-profile California e-pedigree program, which had been set to go into effect by Januar y 2009, was extended by two years in March. The extension is intended to give the industry more time to develop track-and-trace standards and to help pharmaceutical makers better absorb the multimillion-dollar investments in hardware and software that will be required to comply with what observers expect will be a nationwide mandate over time Addressing e-pedigree compliance and the larger supply chain visibility issue will be no easy task. Cost is a huge factor, with companies looking at investments in additional enterprise software, along with new scanners and other equipment associated with bar codes or radio frequency identification (RFID) technology. The latter technolo- keeping track June 2008 49

Table of Contents Feed for the Digital Edition of Managing Automation - June 2008

Managing Automation - June 2008 Contents Take 1 SAP Cites Functionality, Cost Structure in Modified On-Demand Product Rollout Dassault Exec Predicts More PLM Consolidation The Blackberry Goes Native with SAP CRM QAD Brings MDM In-House with FullTilt Buy Power Experts Look to End Voltage Sags The Progressive Manufacturers Notes Cover Story: Playing the Globalization Game to Win Special Report Integration Transformation Industries Product Scan Advertiser Index Next

Managing Automation - June 2008

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