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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
 
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

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

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.

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

Maximizing Profitability and Customer Service in Banking with Automated Financial Transactions
sponsored by IBM
ANALYST REPORT: Access this report today to learn how a single, central, open architecture solution that integrates disparate systems can improve financial institutions' profit margins, compliance, and customer satisfaction.
Posted: 26 Jan 2015 | Published: 21 Jul 2014

IBM

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

How ObserveIT Helped AIG to Pioneer a User-Centric Security Strategy
sponsored by ObserveIT
WEBCAST: This webcast describes how global insurance company AIG benefited from a user activity monitoring solution from Observe IT.
Posted: 28 Oct 2014 | Premiered: Oct 28, 2014

ObserveIT

One Easily Avoidable Pitfall in Your eDiscovery and Compliance Strategy
sponsored by CommVault
WHITE PAPER: This white paper explains the challenges of big data and highlights one common pitfall organizations fall into when dealing with their eDiscovery and Compliance strategy. It also highlights how a solution from CommVault can help avoid this pitfall by delivering searchable endpoint data for more comprehensive searches.
Posted: 28 Apr 2014 | Published: 28 Apr 2014

CommVault

Safeguard Enterprise Compliance and Remain Vigilant Against threats.
sponsored by IBM
WHITE PAPER: This white paper discusses the challenges organizations face due to changing risk and compliance requirements.
Posted: 27 Feb 2015 | Published: 27 Feb 2015

IBM
 
 
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