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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
 
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.

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

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

6 Strategies for Future-Proofing Your Business
sponsored by Sage Software - Live
WHITE PAPER: Your business may be competitive today, but how will it perform in the future? Discover 6 strategies for future-proofing your business, and learn how to uniquely position your organization within your market to boost competitive advantage.
Posted: 16 Jun 2016 | Published: 16 Jun 2016

Sage Software - Live

A New Age of Selling: Work Like a Network to Grow Your Business
sponsored by Microsoft
WHITE PAPER: How can sales organizations use technology to close more deals with less effort? Access now to see concrete examples of successful sales leaders who are transforming the way they sell their solutions.
Posted: 07 Apr 2016 | Published: 01 Jul 2014

Microsoft

Best practices in managing requirements in Energy and Utilities industries
sponsored by IBM
WEBCAST: This webcast highlights some of the compliance and collaboration challenges facing the extended nuclear ecosystem, describe a potential solution that can aid addressing the challenges, and present several examples of where the solution has been implemented in the nuclear space.
Posted: 27 Mar 2014 | Premiered: May 31, 2013

IBM

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

Records management strategies to maintain regulatory compliance
sponsored by SearchCompliance.com
EBOOK: Data governance needs and mandates make compliant records management difficult in the digital age. In this handbook, learn records and information management strategies to avoid regulatory complications, including mobile device management strategies and how retention/deletion schedules can help – and sometimes hurt – compliant records management.
Posted: 16 Apr 2015 | Published: 16 Apr 2015

SearchCompliance.com

Protect People, Processes and Technology from Web Application Threats
sponsored by IBM
WHITE PAPER: Securing externally facing applications is an important step toward safeguarding your critical assets. Find out why.
Posted: 08 Oct 2014 | Published: 29 Nov 2013

IBM
 
 
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