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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
 
Safety analysis in safety-critical systems development
sponsored by IBM
WHITE PAPER: This paper explores how medical device can seamlesslyembed methodologies such as hazard analysis, fault tree analysis (FTA)and failure mode effects analysis (FMEA) into their developmentprocesses—helping them develop safe, FDA-compliant products.
Posted: 20 Mar 2015 | Published: 31 Oct 2014

IBM

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

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

Transitioning from Log Management and SIEM to Comprehensive Security Intelligence
sponsored by IBM
WHITE PAPER: This white paper discusses how security intelligence addresses these shortcomings and empowers organizations—from Fortune Five companies to midsize enterprises to government agencies— to maintain comprehensive and cost-effective information security. It will show how security intelligence addresses critical concerns in five key areas.
Posted: 31 Jul 2014 | Published: 31 Jan 2013

IBM

Accounts Payable Automation: 12 Steps to Kick Your Paper Habit
sponsored by Esker Inc.
WHITE PAPER: The cost of paper usage in Accounts Payable (AP) departments is high. It prevents assurance of timely and accurate payments and fails to provide your business with a competitive edge. Access this accounts payable guidebook for 12 steps to kick your paper habit.
Posted: 28 Jan 2015 | Published: 28 Jan 2015

Esker Inc.

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

Lake Health Enhances Patient Experience with HP ArcSight
sponsored by Hewlett-Packard Company
CASE STUDY: Uncover the SIEM a healthcare provider put in place which helped them take a proactive approach to information security, mitigate anomalies, increase visibility, ensure regulatory compliance, and more!
Posted: 05 Jun 2014 | Published: 31 Jan 2014

Hewlett-Packard Company
 
 
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