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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

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

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

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.

Three Ingredients for Improving Efficiency through the Cloud
sponsored by Red Hat
WHITE PAPER: This white paper introduces a methodology for effectively combining people, processes, and technology for successful cloud implementation, and refers to real-life examples of organizations following these steps to build highly efficient and effective infrastructures.
Posted: 23 Jun 2015 | Published: 23 Jun 2015

Red Hat

Securing Enterprise Networks with a Sharp Eye and a Clear Plan
sponsored by SearchSecurity.com
EBOOK: Enterprise networks are increasing in size and complexity, creating a larger attack surface for hackers. This TechGuide walks you through gaining visibility into your network and devising an effective security strategy.
Posted: 14 Aug 2014 | Published: 11 Aug 2014

SearchSecurity.com

Managing Enterprise Applications Workloads in the Cloud
sponsored by IBM
WHITE PAPER: Read this white paper to explore the different types of cloud engagements for application environments. Learn about the benefits and limitations the cloud involves, and the pain points faced when deploying ERP and CRM in cloud environments.
Posted: 20 May 2015 | Published: 20 May 2015

IBM

Protect People, Processes and Technology from Web Application Threats
sponsored by IBM
WHITE PAPER: Securing externally facing applications is an important step toward safeguarding your critical assets. Find out why.
Posted: 08 Oct 2014 | Published: 29 Nov 2013

IBM

Why European Data Protection Law Supports the Use of Managed Security Services
sponsored by Dell SecureWorks
WHITE PAPER: This white paper debunks common misconceptions about European data protection law, considers the characteristics of an excellent Managed Security Services Provider for data protection law purposes, and more.
Posted: 02 Apr 2014 | Published: 31 Aug 2013

Dell SecureWorks

A Prescription for Privacy
sponsored by Symantec Corporation
WHITE PAPER: This white paper examines the challenges surrounding the emerging world of EHR technology, including the requirements that govern the protection of confidential patient data online; the measures that organizations need to take right now to prepare for these upcoming changes to the healthcare industry; and more.
Posted: 14 Jan 2015 | Published: 28 Feb 2014

Symantec Corporation
 
 
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