Press release
Genzyme Ireland deploys Werum's MES
PAS-X is a central IT building block for the paperless manufacturing strategy in Genzyme's Waterford plantLueneburg, Germany, June 27, 2007 - Genzyme, one of the world's leading biotechnology companies, has deployed the Manufacturing Executions System (MES) PAS-X from the software specialist Werum Software & Systems at their production site in Waterford, Ireland. Genzyme's Waterford manufacturing facility is, among others, the primary tabletting and bottling centre for the successful kidney dialysis drug Renagel®.
Genzyme has a total of seven manufacturing sites in Europe. Its Waterford plant serves as its major European production and distribution centre for large volume runs of its range of products. Genzyme has made its Waterford site a state-of-the-art manufacturing facility which sets new standards of excellence in quality, compliance and efficiency. The implementation of an MES has been an essential step towards reaching this status. Werum's PAS-X significantly drives Genzyme's right-first-time and real-time-release strategy in manufacturing by introducing paperless electronic batch recording.
PAS-X is a standard off-the-shelf product specifically designed for the pharmaceutical and biopharmaceutical industries. It helps in streamlining manufacturing processes, improving product quality, decreasing product cycle times, increasing equipment efficiency and assuring compliance within GMP- and FDA-regulated production and packaging environments.
Genzyme's use of the software modules from the PAS-X portfolio enables the coverage of a broad spectrum of functionality. The core functions include recipe creation (MBR), weighing (WD), electronic batch recording (EBR), warehouse management (WMS), material tracking (MT), and deviation management (DM). The MES system is a central building block in the IT infrastructure of the facility and links the enterprise administration with the equipment level. PAS-X exchanges data with the business level through an ERP interface and also integrates the shop floor equipment.
The development of the Genzyme facility in Waterford started three years ago with the transformation of a 12,500 m2 building into a state-of-the-art pharmaceutical facility. The facility has an annual capacity to produce and pack 800 batches.
In parallel with the implementation, Genzyme has started to build a further expansion of the pharmaceutical site. The Renal Expansion building is occupying 7,500 m2 and will provide Genzyme Waterford with a 100% increase in tabletting capacity by implementing the latest state of the art tablet manufacturing process.
About Werum
Werum Software & Systems (www.werum.com) is a leading supplier of Manufacturing Execution Systems for the pharmaceutical and biopharmaceutical industry worldwide. Twelve of the world's top 20 pharmaceutical companies use Werum's product suite PAS-X to run their manufacturing business. Outstanding PAS-X features are the functions ensuring compliance and boosting performance. The modular system suite includes components for Production Planning and Scheduling, Master Batch Record Management, Electronic Batch Recording, Weighing and Dispensing, Material Flow Control and Tracking, Equipment Integration, Warehouse Management, Quality Management, and Performance Management based on KPI Analysis. Werum’s solutions and services range from software consulting, creation of functional specifications, and software development to turn-key delivery of integrated and validated Manufacturing Execution Systems. Founded in 1969, the IT company employs more than 290 people in its headquarters in Lueneburg, Northern Germany, the regional offices in West and Southwest Germany, and the subsidiary in Parsippany, New Jersey, USA.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
Werum Software & Systems, Tel. USA +1 (973) 644-4000, Tel. Europe +49 (0)4131 8900-0, Press Contact: Volker Mensing, mensing@werum.com
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