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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
 
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.

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

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

Business-driven data privacy policies - Establish and enforce enterprise data privacy policies to support compliance and protect sensitive data.
sponsored by IBM
WHITE PAPER: This resource offers insight to help you establish and enforce business-driven data privacy policies. Read on to learn how to comply with privacy regulations, navigate data governance requirements, and more.
Posted: 27 Feb 2014 | Published: 28 Feb 2013

IBM

Case Study: Computrace Helps HealthSpring Comply with HIPAA and the HITECH Act
sponsored by Absolute
CASE STUDY: This brief case study explains how the healthcare organization HealthSpring effectively supports and secures its increasingly mobile workforce – all while complying with HIPAA and HITECH regulations. Read on to learn more now.
Posted: 13 Nov 2013 | Published: 31 Dec 2012

Absolute

Data Privacy: Where Should I House My Data?
sponsored by IntraLinks, Inc
WHITE PAPER: This white paper offers 6 top recommendations on how to keep your data protected in the cloud and compliant with varying regulatory mandates across country borders.
Posted: 17 Apr 2014 | Published: 17 Apr 2014

IntraLinks, Inc

E-Discovery Cross-Border Data Compliance
sponsored by Exterro
WHITE PAPER: This white paper highlights two popular cross-border cases and recent developments in global data privacy laws, while also addressing common questions that legal teams are presented when faced with cross-border e-discovery issues and best practices for improving e-discovery and regulatory cross-border privacy processes.
Posted: 16 Apr 2014 | Published: 16 Apr 2014

Exterro

Beyond Passwords: Protect the mobile enterprise with smarter security solutions
sponsored by IBM
WHITE PAPER: Find out how flexible authentication schemes, context-based access and behavioral analysis can help ensure that only authorized mobile users can access your valuable resources—on-site, in the cloud and beyond.
Posted: 09 Oct 2014 | Published: 30 Sep 2013

IBM

Sunbelt Exchange Archiver (SEA): Your Email Archiving Solution
sponsored by RSA
PRODUCT LITERATURE: SEA is a comprehensive email archiving solution from Sunbelt Software that effectively addresses today's corporate email communication needs.
Posted: 17 Feb 2014 | Published: 29 Aug 2008

RSA
 
 
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