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FDA 21 CFR 11

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FDA 21 CFR 11Reports
 
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

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

Key IT Influencers in the Banking, Finance, and Insurance Industries in 2014
sponsored by Sungard
WHITE PAPER: Written in conjunction with industry leaders across Banking, Finance, and Insurance, the BFI Key Influencers Report sets out to promote conversation on the future of IT by talking to those industry professionals who help to shape it.
Posted: 24 Sep 2014 | Published: 24 Sep 2014

Sungard

The Increasing Value of Data in Australia: Privacy, Security and Compliance
sponsored by NTT Communications ICT Solutions and Hitachi Data Systems
VIDEO: Access this video to learn how 150 other organizations are evolving in terms of data management. You'll also learn about new technologies as well as areas where organizations are still frequently exposed to risks.
Posted: 01 Oct 2014 | Premiered: 03 Sep 2014

NTT Communications ICT Solutions and Hitachi Data Systems

PCI Data Security Compliance & BYOD
sponsored by BitGlass
WHITE PAPER: This whitepaper shares five important practices to follow in order to make sure data is properly secured and monitored in a PCI-DSS compliant fashion.
Posted: 10 Oct 2014 | Published: 10 Oct 2014


ViaLumina Executive Brief Series: Information Governance: The Time is Now
sponsored by Hewlett-Packard Company
WHITE PAPER: Read this white paper and find out why senior management needs to step up and implement an information governance strategy.
Posted: 26 Aug 2014 | Published: 26 Aug 2014

Hewlett-Packard Company

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

NTT Communications ICT Solutions and Hitachi Data Systems

Lake Health Enhances Patient Experience with HP ArcSight
sponsored by Hewlett-Packard Company
CASE STUDY: Uncover the SIEM a healthcare provider put in place which helped them take a proactive approach to information security, mitigate anomalies, increase visibility, ensure regulatory compliance, and more!
Posted: 05 Jun 2014 | Published: 31 Jan 2014

Hewlett-Packard Company
 
 
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