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FDA 21 CFR 11

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FDA 21 CFR 11Reports
 
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

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

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.

Mobile File Sharing: Balancing Productivity, Security, and Control
sponsored by Acronis
WHITE PAPER: This solution brief highlights the challenges organizations feel in the face of IT consumerization and BYOD trends. It also mentions one solution that improves the productivity of mobile file sharing without sacrificing security or compliance.
Posted: 21 Jul 2014 | Published: 31 Mar 2014

Acronis

Selecting Data Archiving Tools and Successful DR Planning
sponsored by Rand Secure Data
EGUIDE: In this expert e-guide, learn how to carefully plan for disaster recovery and avoid mishaps with 10 common mistakes such as confusing high availability with disaster recovery as well as trying to back up too much.
Posted: 19 Aug 2014 | Published: 19 Aug 2014

Rand Secure Data

CW Europe – September Edition
sponsored by ComputerWeekly.com
EZINE: In this issue of CW Europe read how data discipline ensures you avoid data loss, as well as helping you to think clearer and to be organised.
Posted: 04 Sep 2013 | Published: 04 Sep 2013

ComputerWeekly.com

For regulated industries: Learning within a multi-tenant SaaS architecture
sponsored by SuccessFactors
WHITE PAPER: This resource describes the need for compliance with Good Practice requirements in regulated industries, explores key challenges of the validation process for learning environments, and evaluates whether multi-tenant SaaS architecture is a viable option.
Posted: 20 Feb 2014 | Published: 31 Dec 2013

SuccessFactors

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

Keeping Distributed Endpoints Safe and Compliant
sponsored by IBM
WHITE PAPER: Keeping distributed endpoints safe and compliant has become a costly, complex and time consuming task. In this resource uncover how to overcome these challenges with an approach that provides real-time visibility and control over endpoints and quickly remediates issues to help ensure continuous security and compliance.
Posted: 12 May 2014 | Published: 30 Jun 2012

IBM
 
 
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