FDA ( Food and Drug Administration) Definition

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May 17, 2008

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FDA

-- 9 Vendor Reports

ALSO CALLED: Food and Drug Administration
DEFINITION: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

Recent Vendor Reports on FDA
Speeding the Cure: Kalypsys Deploys Xerox DocuShare CPX to Accelerate Drug Development sponsored by Xerox DocuShare CASE STUDY: Posted: 08 May 2008 \| Published: 01 Jan 2007 SUMMARY: Learn how Kalypsis, a clinical stage pharmaceutical company, is leveraging Xerox DocuShare Enterprise Content Management to control content for regulatory operations and clinical trials. TOPICS: Business Process Management \| Business Processes \| FDA \| FDA Compliance

Mitigating Supply Chain Risk Using Collaborative Technology sponsored by Infinity QS WHITE PAPER: Posted: 30 Apr 2008 \| Published: 01 May 2007 SUMMARY: This whitepaper addresses the trends surrounding Supply Chain Risk Management (SCRM) and the strategies that manufacturers are using to mitigate risk from their supply network. It contains a case study about how one manufacturer is viewing real-tim... TOPICS: FDA \| Manufacturing \| Supply Chain Management

Enterprise Technology: Food and Beverage sponsored by SoftBrands, Inc. PODCAST: Posted: 23 Apr 2008 \| Premiered: 23 Apr 2008 SUMMARY: This podcast is the compilation of three individual podcast which were done in 2007, in which the food safety issues were discussed regarding the inventory control, lab trace and yield management as it pertains to food and beverage manufacturing. TOPICS: Consumers \| FDA \| Manufacturing Industry

Implementing Breakthrough Technology for Clinical Development Modeling and Simulation sponsored by Univa UD CASE STUDY: Posted: 03 Apr 2008 \| Published: 01 Apr 2008 SUMMARY: Using the selection algorithm to pick better models faster - and then running more models at a time using the grid - has allowed the Research, Modeling and Simulation team to achieve significant productivity gains. TOPICS: Cluster Computing \| Cluster Management \| Data Centers \| FDA \| FDA Compliance \| Grid Computing

Traceability 2.0: Ensuring Food Safety and Achieving Competitive Differentiation through Multi-Dimensional Traceability sponsored by CDC Software - Ross Enterprise WHITE PAPER: Posted: 17 Mar 2008 \| Published: 01 Mar 2008 SUMMARY: The benefits of automated Multi-Dimensional Traceability are compliance with increasing regulatory and industry standards, greater efficiency, competitive differentiation through improved quality, and ultimate brand protection assurance. TOPICS: Business Process Automation \| FDA \| FDA Compliance \| Food and Beverage Industry \| Manufacturing Industry \| Quality Control Staff \| Risk Management \| Supply Chains

ERP Software Acquisition in an FDA Regulated Environment sponsored by SoftBrands, Inc. WHITE PAPER: Posted: 14 Mar 2008 \| Published: 12 Mar 2008 SUMMARY: 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. 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

Healthcare 2015: Win-win or Lose-lose? sponsored by IBM Line of Business WHITE PAPER: Posted: 22 Feb 2008 \| Published: 01 Jan 2006 SUMMARY: There is a more positive scenario - a "win-win" - but it is one that will require new levels of accountability, tough decisions and hard work on the part of all stakeholders. TOPICS: Demographics \| FDA \| Governments \| Healthcare Industry \| HIPAA \| Privacy \| Security

Medical Device Makers Tackle FDA Rules with PLM sponsored by CIO Decisions JOURNAL ARTICLE: Posted: 05 Mar 2007 \| Published: 01 Mar 2007 SUMMARY: Jeanne Iasella is governed by regulations. Iasella is the CIO at Medrad Inc., a $411-million company that makes devices for imaging and diagnostic procedures. TOPICS: Business Performance Management \| FDA \| FDA Compliance \| Health Care Industry \| Life Sciences Industry \| Manufacturing Execution Systems \| PLM \| PLM Software

Bitpipe Industry Guide: Healthcare Industry sponsored by Bitpipe WHITE PAPER: Posted: 13 Feb 2006 \| Published: 13 Feb 2006 SUMMARY: Our Healthcare Industry page is the place to start if you need to stay up-to-date on related subject areas, such as Medical Hardware and Software, Telemedicine, and Biotechnology. TOPICS: FDA \| FDA Compliance \| Health Care Applications Software \| Health Care Industry \| HIPAA \| HIPAA Compliance \| Medical Records Management \| Pharmaceutical Industry \| Telemedicine

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