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FDA 21 CFR 11

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FDA 21 CFR 11Reports
 
Beyond Compliance and the FDA Unique Device Identification Rule - How to Achieve Global Standardization
sponsored by LANSA
WHITE PAPER: This brief resource explores what the US Food and Drug Administration (FDA) Unique Device Identification (UDI) Rule is, why it was created, and how GS1 standards can be used to achieve compliance. Read on now to learn more.
Posted: 20 Feb 2014 | Published: 20 Feb 2014

LANSA

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

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

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.

Federal Cyber Security Market Opportunities for EMC Isilon Scale-Out Network-Attached Storage
sponsored by EMC & Arrow
WHITE PAPER: This white paper explains the role of EMC Isilon in terms of cyber security. The paper focuses on the increasing importance of cyber threat information and the need for storage solutions that can keep up with increasing demands.
Posted: 23 Apr 2014 | Published: 28 Jun 2013

EMC & Arrow

Concur Travel and Expense solution
sponsored by Concur Technologies
WHITE PAPER: This guide talks about a solution that allows users to capture all of their travel and expense information digitally and present it all in an accurate automated report.
Posted: 24 Mar 2014 | Published: 31 Dec 2013

Concur Technologies

Legal briefing: The Draft EU General Data Protection Regulation
sponsored by ComputerWeekly.com
ESSENTIAL GUIDE: This report from law firm Morrison & Foerster, sets out some of the most important changes for private sector organisations in the draft EU Data Protection Regulation.
Posted: 28 Jan 2014 | Published: 28 Jan 2014

ComputerWeekly.com

The Secrets of Agile Management
sponsored by Hewlett-Packard Company
ANALYST REPORT: In this article, industry leader Matthew Stibbe reveals how the principles of software development can offer new ideas to business management.
Posted: 07 Feb 2014 | Published: 06 Dec 2013

Hewlett-Packard Company

Million Dollar HIPAA Penalties for Healthcare
sponsored by Absolute Software
WEBCAST: The threat of million dollar penalties from HIPAA regulations is making Healthcare Organizations re-evaluate their patient information security infrastructure. Watch this recorded webcast to see how your organization can reduce the risk.
Posted: 11 Nov 2013 | Premiered: Nov 11, 2013

Absolute Software
 
 
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