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FDA 21 CFR 11

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FDA 21 CFR 11Reports
 
Beyond Compliance and the FDA Unique Device Identification Rule - How to Achieve Global Standardization
sponsored by LANSA
WHITE PAPER: This brief resource explores what the US Food and Drug Administration (FDA) Unique Device Identification (UDI) Rule is, why it was created, and how GS1 standards can be used to achieve compliance. Read on now to learn more.
Posted: 20 Feb 2014 | Published: 20 Feb 2014

LANSA

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 drug’s effects on the body.
Posted: 03 Apr 2008 | Published: 01 Apr 2008

Univa UD

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

SoftBrands, Inc.

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

Xerox DocuShare

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

Apriso Corporation

October 2013 Health IT E-Zine
sponsored by SearchHealthIT.com
EZINE: In this issue of Pulse, readers will get the latest pros and cons of signal extension systems like distributed antenna systems and femtocells and best practices for implementing technologies to support 2014's health IT initiatives and big data projects.
Posted: 11 Oct 2013 | Published: 11 Oct 2013

SearchHealthIT.com

Predictive Coding: The Next Frontier in eDiscovery
sponsored by Rand Secure Data
WHITE PAPER: This resource explores your options for eDiscovery and describes how one strategy – predictive coding – is fueling eDiscovery transformation.
Posted: 18 Mar 2014 | Published: 18 Mar 2014

Rand Secure Data

EU Regulation 1169/2011 and its Influence on US Manufacturers and Retailers
sponsored by LANSA
WHITE PAPER: EU Regulation 1169/2011 is working to combat product data mismanagement in Europe, but what does this regulation mean for US manufacturers and retailers? Find out by reading on now.
Posted: 14 Feb 2014 | Published: 14 Feb 2014

LANSA

A Prescription for IT Efficiency
sponsored by Dell, Inc. and Windows 8 Pro
WHITE PAPER: This resource examines new risks and threats that are making Windows XP unsafe for use in a healthcare setting, and details the essential security capabilities and benefits offered by Windows 7 and Windows 8.
Posted: 04 Nov 2013 | Published: 04 Nov 2013

Dell, Inc. and Windows 8 Pro

Case Study: Computrace Helps HealthSpring Comply with HIPAA and the HITECH Act
sponsored by Absolute Software
CASE STUDY: This brief case study explains how the healthcare organization HealthSpring effectively supports and secures its increasingly mobile workforce – all while complying with HIPAA and HITECH regulations. Read on to learn more now.
Posted: 13 Nov 2013 | Published: 31 Dec 2012

Absolute Software
 
 
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