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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

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

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

MicroScope - July 2017: Data and storage are the themes, with GDPR and flash up for debate
sponsored by MicroScope
EZINE: An issue looking at the issues around flash storage, EU General Data Protection Regulation (GDPR), hardware as a service and cloud platforms.
Posted: 30 Jun 2017 | Published: 30 Jun 2017

MicroScope

Beyond Nine to Five
sponsored by ComputerWeekly.com
BOOK: In this extract from his book, Ade McCormack offers guidance to enable you to move forward in your career with the minimum of anxiety as digital technology fundamentally changes the nature of work.
Posted: 17 Aug 2015 | Published: 17 Aug 2015

ComputerWeekly.com

Best practices in managing requirements in Energy and Utilities industries
sponsored by IBM
WEBCAST: This webcast highlights some of the compliance and collaboration challenges facing the extended nuclear ecosystem, describe a potential solution that can aid addressing the challenges, and present several examples of where the solution has been implemented in the nuclear space.
Posted: 27 Mar 2014 | Premiered: May 31, 2013

IBM

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

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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