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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
 
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.

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

Overcome the challenges of large database footprints and avoid business disruption during migration
sponsored by Oracle Corporation
RESOURCE: CSX, a premier transportation company, has a large Oracle Database footprint, with over 400 databases supporting critical business apps. CSX upgraded to Oracle Database 11g to ensure high performance and maintain business continuity. Access this resource to learn how CSX minimized business impact and downtime during the migration.
Posted: 28 Apr 2015 | Published: 28 Apr 2015

Oracle Corporation

Five Must-Haves for Enterprise File Sync and Share Flexibility
sponsored by Code42
WHITE PAPER: This is why it's vital to have an enterprise-grade sync and share solution in place, but what constitutes enterprise grade? Read this whitepaper for five must-haves for enterprise sync and share flexibility.
Posted: 13 Oct 2014 | Published: 13 Oct 2014

Code42

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

Sharing knowledge to tackle online banking fraud
sponsored by ComputerWeekly.com
ESSENTIAL GUIDE: This article in our Royal Holloway Security Series argues that an information sharing service between national banking systems and law enforcement agencies could counteract online fraud.
Posted: 22 Jul 2014 | Published: 22 Jul 2014

ComputerWeekly.com

Email Security Checklist: Eight Steps for Healthcare Organizations
sponsored by Mimecast
WHITE PAPER: This white paper explains how you can embrace email as a core communication tool while still adhering to HIPAA guidelines.
Posted: 18 Dec 2014 | Published: 18 Dec 2014

Mimecast

Securing Enterprise Networks with a Sharp Eye and a Clear Plan
sponsored by SearchSecurity.com
EGUIDE: 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
 
 
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