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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
 
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

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

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

CIO Trends ANZ Q1 2016
sponsored by ComputerWeekly.com
ESSENTIAL GUIDE: This guide offers a collection of our most popular articles for IT leaders in Australia and New Zealand during the first few months of 2016, examining the changing role of CIOs and how to enhance their relationships with their peers across the business.
Posted: 17 Mar 2016 | Published: 17 Mar 2016

ComputerWeekly.com

Expert Guide to Information Security Certifications
sponsored by TechTarget
RESOURCE: Choosing the right information security certification, whether it is for your educational or career benefit should be easy. Find a list of programs from various vendors, a brief description of each and tips on identifying the right one for your needs in our expert information security guide, upon completion of a brief Data Protection Survey.
Posted: 18 Mar 2014 | Published: 18 Apr 2014

TechTarget

GDPR Developments Will Dominate Storage and Compliance in 2017
sponsored by Arrow + NetApp
EGUIDE: In this expert guide, Storage Editor Antony Adshead and CEO of Vigitrust, Mathieu Gorge, discuss 2017's developments in the GDPR, as it pertains to regulatory compliance, and data backup. Read on to discover backup challenges associated with e-discovery, the evolution of data retention regulations, and more.
Posted: 17 May 2017 | Published: 11 May 2017

Arrow + NetApp

Meeting Solvency II 'Full Measures' XBRL Reporting Requirements and More
sponsored by IBM
WHITE PAPER: Explore this white paper to discover technology that can enable you to minimize complexity caused by requirements of regulations like the Solvency II mandate while improving efficiency at the same time. Learn how you can reduce process risks, costs, and data inaccuracies that stem from manual reporting processes.
Posted: 28 Jul 2016 | Published: 31 Dec 2015

IBM

Managing User Identities and Access in the Cloud
sponsored by IBM
WHITE PAPER: Learn how IBM can help design, deploy and manage critical identity and access management controls in cloud environments.
Posted: 08 Oct 2014 | Published: 30 Dec 2011

IBM

How To Know If Your Organization Is Ready For Data Governance Software
sponsored by Veritas
EGUIDE: It's important to ensure your organization is ready for a governance tool, or your software purchase is likely to fall flat. This e-guide takes a look at three different scenarios where data governance tools are often used to help you determine if your organization is ready for data governance software.
Posted: 10 Oct 2016 | Published: 05 Oct 2016

Veritas
 
 
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