Brazil regulatory requirements

Cranbury, New Jersey, May 24, 2011 - Systech International, innovator of Packaging Execution Systems (PES) , and our Brazilian Partner Videojet today announced that one of the world’s largest pharmaceutical manufacturers has chosen to implement Systech’s Serialized Product Tracking (SPT) solution on each of its packaging lines in Brazil. The manufacturer will employ Systech SPT to meet Brazil’s pending anti-counterfeiting track and trace requirement, Law 11.903.

“Pharmaceutical counterfeiting is a global problem that is growing rapidly,” notes Joe Ringwood, COO Systech International. “In response, more countries like Brazil are legislating regulatory requirements that require item, case and pallet level serialisation. Our serialisation solution has been deployed worldwide by companies addressing various anti-counterfeiting requirements. We’re thrilled to help this top manufacturer efficiently address Brazil’s pending legislation and guard their supply chain from dangerous, illegitimate products.”

Brazil’s Law 11.903, which was passed in 2009, requires the “tracking of manufacturing and consumption of medicine by means of data capturing, storing, and electronic transmission technology.” To address this mandate, the manufacturer required an end-to-end solution capable of the following:

Item-level serialisation Aggregation of items into cases and cases into pallets Inspection of tamper-evident labeling over carton end flaps Inspection of a security label to be distributed by ANVISA Centralised palletising Post-lot re-work Full integration into SAP Aii Flexibility to accommodate any current or future regulations After evaluating the market, the manufacturer found that only Systech’s offering is able to meet each of these requirements. Systech SPT, a widely deployed serialisation solution for the global pharmaceutical industry, allocates and verifies unique identification numbers at the item level. If aggregation of serialisation data is required, such as in Brazil, the solution then packages the item (child) into a higher level package (the parent), thereby establishing relevant parent-child relationship between item, case, and pallet. The solution also maintains data integrity throughout the entire packaging process, thus ensuring that the manufacturer’s serialisation and aggregation data are accurate. This enables the manufacturer to successfully track products and verify their legitimacy throughout their entire journey in the supply chain. As a result, the manufacturer can meet regulatory requirements aimed at protecting patient safety while also protecting the integrity of their brands.

Systech SPT can also fully integrate into SAP Aii without requiring third party software to do the middleware between the line and SAP. What’s more, the solution is configurable, enabling it to easily and quickly accommodate multiple requirements and changing demands without requiring code re-writes. With Brazil’s legislation still subject to changes, and in light of the diversity in global regulations, the manufacturer realized the strategic importance of implementing a solution with this built-in flexibility.

Additionally, Systech’s partnership with Videojet Brazil was a key factor in the manufacturer’s decision to employ SPT. Videojet, a leading supplier of encoding and marking solutions, sells, installs, and supports Systech’s SPT solution in Brazil. Videojet Brazil has significant experience and expertise deploying its coding and marking solutions on pharmaceutical packaging lines throughout Brazil as well as deploying complex hardware and software integrations.

“We’re pleased that this manufacturer sees the strategic value in SPT and the partnership between Systech and Videojet,” states Andre Santos, Country Manager, Videojet Brazil. “Our training and in-region support will significantly help this manufacturer successfully implement SPT and meet Brazil’s regulatory requirements.”

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About Systech International

Systech International is an innovator of packaging execution systems (PES) for the pharmaceutical industry. Systech offers a suite of productised software that quickly gives manufacturers complete control over packaging processes along with the actionable intelligence required to continuously improve performance. Systech implements vision, line management, performance metric and serialisation solutions for companies around the world to secure the supply chain and to optimize packing efficiencies. By partnering with Systech, companies can leverage a repeatable, flexible, and expandable architecture to consistently deliver significant improvements at the machine, line and plant levels. For more information about their company and products, please visit www.systech-tips.com . About Videojet

Videojet Technologies Inc. is a world-leading manufacturer of coding, printing and laser marking products, fluids, and accessories for the product identification industry. As experts in continuous ink jet (CIJ), drop-on-demand (DOD), thermal transfer overprinting (TTO), array, and laser technologies, Videojet has over 275,000 units installed worldwide. Sales, service, training, administrative and application support is provided by direct operations worldwide, including Austria, Brazil, Canada, Chile, China, France, Germany, India, Ireland, Japan, Korea, the Netherlands, Poland, Portugal, Russia, Singapore, Spain, Switzerland, Turkey and the United Kingdom, with more than 250 direct sales and service personnel in the United States alone. Videojet’s distribution network includes over 175 distributors and OEMs, serving 135 countries.

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Brazil regulatory requirements

Top Pharmaceutical Manufacturer Selects Systech to Meet Brazil’s Anti-Counterfeiting Regulatory Requirements

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