FDA Validation Software aids life science operations.
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Press Release Summary:
The iRenaissance® Validator is for manufacturing processes and related information. Master action plan, templates, and test scripts complete IQ, OQ, and PQ processes. System defines and thoroughly documents each step to achieve and maintain validation. Suite includes ERP II enterprise resource planning, supply chain management, and customer relationship management applications. Software provides traceability, quality and shelf-life management, and expiration date control.
Original Press Release:
Ross Systems Streamlines FDA Compliance with New Validation Application
iRenaissance Validator provides a proven process for predictably validating manufacturing processes and related information in iRenaissance ERP
ATLANTA November 13, 2002 - Ross Systems, Inc. (NASDAQ: ROSS), a leading provider of enterprise software solutions for process manufacturers, today announced the availability of iRenaissance Validator for pharmaceutical and biotechnology companies in manufacturing or clinical trials. The iRenaissance Validator substantially reduces the efforts, costs and risks created by increasingly stringent FDA regulations.
"The FDA has become such a formidable business risk in Life Science operations that manufacturers now acknowledge that they have two customers: the consumer and the FDA. They need to take a coordinated and top-down approach to regulatory compliance that will intensify as manufacturers use more IT to improve productivity through automated processes, electronic record management, and integration. Manufacturers have little choice but to build regulatory compliance into operations and leverage business process improvement wherever possible--there is nowhere left to hide." Source: Roddy Martin, The AMR Research Alert, September 26, 2002.
With the addition of iRenaissance Validator, iRenaissance becomes the only enterprise system of its kind to include an integrated application for validating manufacturing processes. iRenaissance Validator provides the master action plan, templates and test scripts needed to quickly complete the IQ, OQ, and PQ processes. This comprehensive solution clearly defines and thoroughly documents each step in a proven process to predictably achieve and maintain validation.
"Our core applications are proven to help Life Science companies run their materials management, manufacturing, distribution and quality control operations in compliance with FDA Guidelines," said Eric Musser, Chief Technology Officer at Ross Systems. "Working closely with our customers, we identified the need to facilitate and streamline the validation process for those applications. As a result, iRenaissance Validator is designed to deliver an immediate payback in the form of a greatly simplified validation process with predictable results. Preliminary customer feedback indicates that companies can reduce validation efforts by at least two man-years."
"We are fully committed to helping Life Science companies optimize their business operations and cost-effectively comply with FDA regulations," said J. Patrick Tinley, Chairman and CEO of Ross Systems. "iRenaissance Validator adds significant value to our offering and is a clear demonstration of our strong position in Life Sciences. We will continue to raise the bar for the benefit of our customers."
The iRenaissance suite from Ross Systems includes ERP II (enterprise resource planning), SCM (supply chain management) and CRM (customer relationship management) applications that are designed to address the unique challenges faced by Life Science companies. This comprehensive suite supports CFR 21 Part 11 and delivers the proven capabilities needed to:
Reduce risk through detailed traceability, quality management and change control,
Reduce write-offs through shelf-life management and expiration date control,
Improve profitability through optimized forecasting, detailed costing and analysis, and
Improve customer loyalty through product attribute matching and web-based customer service.
The iRenaissance Validator will be launched at the Bio-IT World Conference and Expo, November 13-14 in San Diego. For more information, visit Ross Systems in booth 609 or on the Internet at www.rossinc.com.
About Ross Systems
Implemented by more than 1,000 customers worldwide, iRenaissance business applications from Ross Systems enable Life Science companies to ensure FDA compliance, minimize the risk of product recalls, accelerate the introduction of new products, effectively manage in-house and out-sourced manufacturing processes, collaborate effectively with suppliers, and ensure customer satisfaction. Ross' Life Science customers include Barr Laboratories, IDEC Pharmaceuticals, Genetics Institute, Cambrex, Boston Biomedica and NaPro BioTherapeutics.
Ross Systems, Inc. listed as (NASDAQ:ROSS) since 1991, is a global supplier of business software solutions designed specifically for Food and Beverage, Life Sciences, Chemicals, Metals, Natural Products and other process manufacturers. The Company's iRenaissance family is a comprehensive, integrated suite that includes ERP II (enterprise resource planning), SCM (supply chain management) and CRM (customer relationship management), electronic commerce, business intelligence and analytics
Ross Systems has more than 25 offices around the world to serve its customers. For more information contact (770) 351-9600, (877) 767-7462, info@rossinc.com, or visit www.rossinc.com.
iRenaissance and GEMBASE are registered trademarks of Ross Systems, Inc. Throughout this release, software and hardware products are mentioned by name. In most, if not all, cases, the companies that manufacture the products claim these product names as trademarks. It is not our intention to claim these names or trademarks as our own.
