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ERP Software Acquisition in an FDA Regulated Environment by SoftBrands, Inc.

March 2008 - (Free Research)
This white paper presents a guideline to help you select an ERP system for your FDA validation. Explore a five phase software acquisition life cycle model to help you accomplish these objectives as efficiently as possible. 
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FlexNet and FDA 21 CFR Part 11 by Apriso Corporation

March 2011 - (Free Research)
Manufacturers regulated by the FDA 21 CFR Part 11 regulations understand that the integrity of manufacturing processes must be achieved and maintained in order to sustain compliance. The purpose of this document is to demonstrate that Apriso FlexNet platform and application suite can support the intent of the 21 CFR Part 11 regulatory guidelines. 
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Implementing Breakthrough Technology for Clinical Development Modeling and Simulation by Univa UD

April 2008 - (Free Research)
When GlaxoSmithKline was challenged with improving efficiency in modeling and simulation, their clinical development research team turned to Univa technology for faster methods of establishing and running models for a drug’s effects on the body. 
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Case Study from IDC: Speeding the Cure: Kalypsys Deploys Xerox DocuShare CPX to Accelerate Drug Development by Xerox DocuShare

May 2008 - (Free Research)
Learn how Kalypsis, a clinical stage pharmaceutical company, is leveraging Xerox DocuShare Enterprise Content Management to control content for regulatory operations and clinical trials. 
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A New Approach to Verifying and Validating Medical Device Development by IBM

December 2010 - (Free Research)
The list of features in medical devices is rapidly rising: Even the simplest of medical devices house more and more system components, which add greater functionality to the device at a low cost. But by adding components, device software becomes complex and burdens compliance testing and premarket certification activities. 
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CW+: Analyst's take: Benefits of Siemens product lifecycle management software for life sciences by ComputerWeekly.com

January 2011 - (Free Research)
Siemens product lifecycle management (PLM) Software for life sciences can help medical device manufacturers manage compliance requirements while supporting greater collaboration, ultimately reducing costs while improving patient outcomes. 
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Sage ERP X3 Helps Aceto Corporation Manage Complicated Compliance Regulations by Sage North America

October 2010 - (Free Research)
This case study explains how with Sage ERP X3, Aceto Corporation’s business processes are streamlined and automated. The company is finding it easier to comply with the financial reporting responsibilities placed on publicly-traded companies. Read on to learn how Aceto benefited from Sage ERP X3. 
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Managing Product Recalls to Reduce Risk and Minimize Cost by Sage North America

January 2009 - (Free Research)
With an integrated enterprise system like Sage ERP X3, food producers can use the same system to address industry-specific requirements and product recalls. 
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ExtraView Enterprise by Extraview Corporation

ExtraView Enterprise enables organizations to quickly and cost-effectively, create user specific web-based solutions that conform to a corporation's unique business processes and workflow requirements. 
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