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FDA 21 CFR 11

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FDA 21 CFR 11Reports
 
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

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

Resolving the Catch-22 of UC&C in Regulated Environments
sponsored by Dimension Data
WHITE PAPER: This white paper explains why organizations in regulated sectors like finance, government, and healthcare have a different set of requirements for cloud-based unified communications and collaboration services, and introduces a suite of email and collaboration tools that meets these needs.
Posted: 30 Sep 2014 | Published: 30 Sep 2014

Dimension Data

Data management strategy good for business and a boost to compliance
sponsored by Hewlett-Packard Company
EGUIDE: In this e-guide, learn what Derek Gascon, Executive Director of the Compliance, Governance and Oversight Council, believes data management can do for business.
Posted: 26 Sep 2014 | Published: 26 Sep 2014

Hewlett-Packard Company

A More Effective Approach to Scalable Data Classification
sponsored by Digital Guardian
WHITE PAPER: This white paper highlights the importance of using a scalable data classification program within your organization.
Posted: 26 Sep 2014 | Published: 26 Sep 2014

Digital Guardian

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

NTT Communications ICT Solutions and Hitachi Data Systems

Manage Data Retention, Access, and Destruction on a Single Scalable Platform
sponsored by Avnet
WHITE PAPER: This white paper introduces Avnet Services' Archive Manager for HP Application Lifecycle Management, designed to store and access HP Quality Center and ALM requirements, tests, runs, and defects on a common platform.
Posted: 09 Oct 2014 | Published: 30 Apr 2014

Avnet

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
 
 
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