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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.

Executive Guide to SYSPRO Security for Auditing Assurance and Control
sponsored by SYSPRO
WHITE PAPER: This white paper introduces an enterprise resource planning (ERP) system with the governance, risk, and compliance functionality you need to satisfy regulatory requirements and fuel security success.
Posted: 03 Apr 2014 | Published: 31 Dec 2013

SYSPRO

Six Steps to SIEM Success
sponsored by AlienVault
WEBCAST: In this webinar, we cover the six key steps every IT practitioner should take to go from installation to insight as quickly as possible with a SIEM solution. You'll learn how to leverage SIEM event correlation to aggregate, correlate and analyze all of the security-relevant log data in your environment.
Posted: 16 Oct 2013 | Premiered: Oct 16, 2013

AlienVault

Core HR Kit: Cut costs, engage your people, and ensure compliance
sponsored by SuccessFactors
WHITE PAPER: This resource offers insight to help you choose an effective core HR system. Read on to discover key benefits of the right tool and learn how you can get started today.
Posted: 04 Mar 2014 | Published: 04 Mar 2014

SuccessFactors

Recognize your Apps Personalities
sponsored by Hewlett-Packard Company
VIDEO: This brief video explains how the right applications transformation strategy can lead your enterprise to a new level of success by enabling you to categorize and profile apps based on business impact, simplify apps management, and more.
Posted: 09 Oct 2013 | Premiered: 09 Oct 2013

Hewlett-Packard Company

Data Center Designs to Help Meet Your Compliance Challenge
sponsored by Iron Mountain
WHITE PAPER: This valuable resource reveals how the right data center services can help you successfully meet your industry-specific regulatory requirements and better support compliance.
Posted: 27 Jan 2014 | Published: 27 Jan 2014

Iron Mountain
 
 
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