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Business of Information Technology  >  Business Environment  >  Legal Environment  >  Laws  >  Regulatory Compliance  >  

FDA Compliance

-- 8 Vendor Reports | 2 Products

ALSO CALLED: FDA 21 CFR 11
DEFINITION: Compliance to FDA regulations.
Recent Vendor Reports on FDA Compliance
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: 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.

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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.

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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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