FDA Compliance White Papers ( FDA 21 CFR 11 ) Software Downloads, Definition and Webcasts

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May 25, 2013

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FDA Compliance
ALSO CALLED: FDA 21 CFR 11 DEFINITION: Compliance to FDA regulations.
FDA Compliance Reports
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FlexNet and FDA 21 CFR Part 11 sponsored by Apriso Corporation WHITE PAPER: 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. Posted: 09 Mar 2011 \| Published: 09 Mar 2011 TOPICS: Business Process Management \| Business Process Management Software \| Cost Benefit Analysis \| Electronic Signatures \| Enterprise Applications Software \| FDA Compliance \| Manufacturing Execution Systems \| Manufacturing Industry \| Manufacturing Software \| Regulatory Compliance

ERP Software Acquisition in an FDA Regulated Environment sponsored by SoftBrands, Inc. WHITE PAPER: 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. Posted: 06 Nov 2008 \| Published: 12 Mar 2008 TOPICS: Application Life-Cycle Management \| ERP \| FDA \| FDA Compliance \| Food and Beverage Industry \| Manufacturing \| Manufacturing Industry \| Manufacturing Software \| Manufacturing Systems \| Medical Software \| Pharmaceutical Industry \| SAP (Product) \| Software Implementation \| Software Selection \| Vendor Selection

Case Study from IDC: Speeding the Cure: Kalypsys Deploys Xerox DocuShare CPX to Accelerate Drug Development sponsored by Xerox DocuShare CASE STUDY: Learn how Kalypsis, a clinical stage pharmaceutical company, is leveraging Xerox DocuShare Enterprise Content Management to control content for regulatory operations and clinical trials. Posted: 08 May 2008 \| Published: 01 Jan 2007 TOPICS: Business Process Management \| Content Management \| Content Management Software \| Content Management Systems \| Document Management \| Document Management Software \| FDA \| FDA Compliance \| Pharmaceutical Industry

Implementing Breakthrough Technology for Clinical Development Modeling and Simulation sponsored by Univa UD CASE STUDY: 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 drugâ€™s effects on the body. Posted: 03 Apr 2008 \| Published: 01 Apr 2008 TOPICS: Cluster Computing \| Cluster Management \| Data Centers \| FDA \| FDA Compliance \| Grid Computing

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