Helsinn Healthcare Streamlines Quality Assurance Globally with Sparta Systems’ TrackWise Software
Holmdel, NJ - April 15, 2008 - Sparta Systems, Inc. (Sparta), the maker of TrackWise®, and the market leader in enterprise quality and compliance management software, today announced Helsinn Healthcare SA, a Swiss-based pharmaceutical licensing company, has selected TrackWise to standardize quality assurance practices in all of its companies and sites across Switzerland and Ireland. The goal is a singular, centralized standard for quality assurance and compliance management corporate-wide.
"We selected Sparta because it represents the highest level of quality management software, and it is distributed all over the world,” said Dr .Giorgio Calderari, Chief Operating Officer, Helsinn Healthcare SA. "The TrackWise system will allow us to harmonize all quality assurance procedures across our businesses for better performance, stricter adherence to our standard operating procedures and better overall visibility into our global operations."
The company plans a staged rollout of TrackWise across the organization to support a number of core processes including deviations, Change Control, corrective and preventative action (CAPA), out of specifications (and out of trend), complaints, audit, training and supplier qualification.
"The drug industry today in the world is strictly regulated by agencies such as European Medicines Agency (EMEA) or Food and Drug Administration (FDA) which scrutinize all drug data and clinical operations to ensure proper adherence to governmental regulations,” said Yaniv Vardi, Vice President, Operations, Sparta Systems Europe. “With years and years of experience supporting the pharmaceutical field globally, we fully understand these challenges and have developed software to provide this stringent level of quality compliance. Helsinn Healthcare SA is a great example of an organization committed to these high levels of quality assurance standards."
Helsinn chose TrackWise to streamline its quality assurance practices in order to achieve the following benefits:
- Accelerate collection of information among different departments
- Better compliance with timelines
- Easier trend and risk analyses
- More effective communication of information among different departments
- Enhance presentation of data at customer and regulatory audits
- Improve efficiency of QA Department
TrackWise will support all Helsinn businesses across Europe including Helsinn Healthcare SA, Helsinn Chemicals Biasca SA, Helsinn Advanced Synthesis SA, Helsinn Chemicals Ireland Ltd and Helsinn Birex Pharmaceuticals Ltd. Together, these Helsinn companies provide drug companies with development and manufacturing services for Active Pharmaceuticals Ingredients and Drug Products.
About Helsinn Healthcare
HELSINN is a privately owned pharmaceutical group with headquarters in Switzerland. Helsinn’s core business is the licensing of pharmaceuticals in therapeutic areas (oncology, cancer supportive care, pain and inflammation, gastrointestinal). The company's business strategy is to in-license early-stage new chemical entities and to complete their development from the performance of pre-clinical/clinical studies and CMC development to the attainment of market approvals in strategic markets (U.S. and Europe). Helsinn’s products are eventually out-licensed to its worldwide consolidated network of partners for distribution. The active pharmaceutical ingredients and the drug products are manufactured at Helsinn’s cGMP facilities and supplied worldwide to its customers. Helsinn’s chemical business focuses on the pharmaceutical chemical process development and manufacturing of advanced intermediates, Active Pharmaceutical Ingredients (APIs) and High Potency Active Ingredients (HPAIs) for both the Helsinn group and its outsourcing partners. For more information about Helsinn, please visit www.helsinn.com.
About Sparta Systems
Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise product is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 12 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise® can be found at www.sparta-systems.com.
Media Contact: Jon RabinowitzDirector of Marketing
Sparta Systems, Inc.
Phone: (732) 203-0400 x121
Email: jon.rabinowitz@sparta-systems.com
Sparta Systems Inc. and the Sparta Systems, Inc. logo, TrackWise and the TrackWise logo are trademarks or registered trademarks of Sparta Systems, Inc.
All other company and product names are used for identification purposes only and may be trademarks of their respective owners. Sparta Systems, Inc. cannot guarantee completion of any of the aforementioned products or product features, and no reliance should be placed on their availability. Sparta Systems does not undertake an obligation to update the forward-looking information contained herein.