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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
 
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

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.

Transitioning from Log Management and SIEM to Comprehensive Security Intelligence
sponsored by IBM
WHITE PAPER: This white paper discusses how security intelligence addresses these shortcomings and empowers organizations—from Fortune Five companies to midsize enterprises to government agencies— to maintain comprehensive and cost-effective information security. It will show how security intelligence addresses critical concerns in five key areas.
Posted: 31 Jul 2014 | Published: 31 Jan 2013

IBM

Managing User Identities and Access in the Cloud
sponsored by IBM
WHITE PAPER: Learn how IBM can help design, deploy and manage critical identity and access management controls in cloud environments.
Posted: 08 Oct 2014 | Published: 30 Dec 2011

IBM

What Can You Do Differently to Guard Against Threats from Rapidly Evolving Mobile Malware?
sponsored by IBM
WHITE PAPER: Mobile security is about more than the device: It's also about protecting apps on the device. Learn how IBM can help.
Posted: 09 Oct 2014 | Published: 31 Jan 2014

IBM

Data Monetization Strategies: Make and Save Money With Data and Analytics
sponsored by Information Builders
WHITE PAPER: Are you sitting on your data with no plan? Do you know how to capitalize on information you already have? This whitepaper dives into the world of profiting from data. Access now to discover 4 essential steps to getting started, as well as challenges to overcome and a discussion on the importance of data integrity.
Posted: 26 Oct 2015 | Published: 26 Oct 2015

Information Builders

For regulated industries: Learning within a multi-tenant SaaS architecture
sponsored by SuccessFactors
WHITE PAPER: This resource describes the need for compliance with Good Practice requirements in regulated industries, explores key challenges of the validation process for learning environments, and evaluates whether multi-tenant SaaS architecture is a viable option.
Posted: 20 Feb 2014 | Published: 31 Dec 2013

SuccessFactors

IDC Flash: IBM Releases IAM for Mobile, Cloud and Enterprise
sponsored by IBM
WHITE PAPER: Gain insights into IBM's threat-aware IAM solutions focused on enabling identity as the new security perimeter.
Posted: 09 Oct 2014 | Published: 29 Nov 2013

IBM
 
 
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