FDA Compliance ( FDA 21 CFR 11) Definition

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May 17, 2008

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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. TOPICS: Business Process Management \| Business Processes \| FDA \| FDA Compliance

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. TOPICS: ERP System \| FDA Compliance \| Medical Devices

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

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. TOPICS: Bioterrorism \| Business Intelligence \| Business Intelligence Software \| CIOs \| ERP \| ERP Software \| FDA Compliance \| Food and Beverage Industry

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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