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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

GDPR Compliance: How Can You Adapt to the New Regulation?
sponsored by CA Technologies.
WHITE PAPER: The General Data Protection Regulation (GDPR) is set to begin in May 2018 – is your organization ready to comply? Learn from a technology perspective what's needed to comply with the GDPR. Topics covered include data breach reporting, accountability, rights and more.
Posted: 08 Sep 2017 | Published: 08 Sep 2017

CA Technologies.

Sharing knowledge to tackle online banking fraud
sponsored by ComputerWeekly.com
ESSENTIAL GUIDE: This article in our Royal Holloway Security Series argues that an information sharing service between national banking systems and law enforcement agencies could counteract online fraud.
Posted: 22 Jul 2014 | Published: 22 Jul 2014

ComputerWeekly.com

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

Infographic: Bridging the Gap Between Business and IT
sponsored by IBM
WHITE PAPER: This infographic illustrates the necessity of integration between business and IT, as well as the fundamental disagreements that exist between the two groups.
Posted: 04 Sep 2014 | Published: 04 Sep 2014

IBM

Four steps to ensure IT investments benefit regulatory compliance
sponsored by Hewlett Packard Enterprise
EGUIDE: In this expert e-guide, discover how companies can ensure new IT investments meet the business's regulatory needs in four simple steps.
Posted: 01 Oct 2014 | Published: 01 Oct 2014

Hewlett Packard Enterprise

E-Discovery Cross-Border Data Compliance
sponsored by Exterro
WHITE PAPER: This white paper highlights two popular cross-border cases and recent developments in global data privacy laws, while also addressing common questions that legal teams are presented when faced with cross-border e-discovery issues and best practices for improving e-discovery and regulatory cross-border privacy processes.
Posted: 16 Apr 2014 | Published: 16 Apr 2014

Exterro
 
 
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