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FDA Compliance

ALSO CALLED: FDA 21 CFR 11
DEFINITION: Compliance to FDA regulations.


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7 Matches
Case Study from IDC: 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.

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TranS1 - Medical Device Manufacturing, FDA Validation
sponsored by SoftBrands, Inc.
WEBCAST:   Posted: 23 Apr 2008 | When: Available On Demand
SUMMARY: Because of SoftBrands unique service, TranS1 was able to achieve validation in just a few weeks without disrupting their software implementation and with minimal staff time required.

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Implementing Breakthrough Technology for Clinical Development Modeling and Simulation
sponsored by Univa UD
CASE STUDY:   Posted: 03 Apr 2008 | Published: 01 Apr 2008
SUMMARY: 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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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.

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Vintage IT No More
sponsored by CIO Decisions
JOURNAL ARTICLE:   Posted: 03 Oct 2007 | Published: 01 Oct 2007
SUMMARY: Korbel CIO Robert Barnes has brought 21st century IT to a 19th century company, fixing an errant ERP project and BI system in the process.

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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.

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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.

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