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FDA 21 CFR 11

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FDA 21 CFR 11Reports
 
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

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.

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

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

The Increasing Value of Data in Australia
sponsored by NTT Communications ICT Solutions and Hitachi Data Systems
WHITE PAPER: This brief infographic gives survey results from 150 organizations and explores more about the impact of changes in regulations.
Posted: 19 Aug 2014 | Published: 19 Aug 2014


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

Executive Guide to SYSPRO Security for Auditing Assurance and Control
sponsored by SYSPRO
WHITE PAPER: This white paper introduces an enterprise resource planning (ERP) system with the governance, risk, and compliance functionality you need to satisfy regulatory requirements and fuel security success.
Posted: 03 Apr 2014 | Published: 31 Dec 2013

SYSPRO

Banking on your Data?
sponsored by NTT Communications ICT Solutions and Hitachi Data Systems
WHITE PAPER: This resource explains the importance of meeting compliance requirements and delivering modern data protection capabilities.
Posted: 19 Aug 2014 | Published: 18 Jun 2014


Reducing the costs and risks of data storage in the federal government
sponsored by IBM
WHITE PAPER: This resource introduces a storage and data management approach that helps reduce storage costs and risks, increase data protection, and much more.
Posted: 29 Oct 2013 | Published: 30 Jun 2012

IBM

Data Center Designs to Help Meet Your Compliance Challenge
sponsored by Iron Mountain
WHITE PAPER: This valuable resource reveals how the right data center services can help you successfully meet your industry-specific regulatory requirements and better support compliance.
Posted: 27 Jan 2014 | Published: 27 Jan 2014

Iron Mountain
 
 
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