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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.

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

Guide to Flexible Working
sponsored by
ESSENTIAL GUIDE: This guide from Vodafone explains how to introduce flexible working, what technologies to consider and how to succeed at implementation.
Posted: 07 Apr 2016 | Published: 07 Apr 2016

Automating Information Governance - assuring compliance
sponsored by
ESSENTIAL GUIDE: This report from AIIM takes an in-depth look at information governance policies, privacy and records management issues, policy enforcement, and how well technology can set or correct metadata, detect security risks, and enforce deletion policies.
Posted: 16 Jun 2014 | Published: 16 Jun 2014

Managing Food Safety and Quality Using Enterprise Software
sponsored by IFS
WHITE PAPER: Access this white paper to learn how to get a solid grip on process manufacturing with the use of software.
Posted: 20 Feb 2015 | Published: 20 Feb 2015


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


Protecting Your Critical Data with Integrated Security Intelligence
sponsored by IBM
WHITE PAPER: Access this white paper to gain actionable insights that can help you reduce security risks and boost compliance.
Posted: 08 Oct 2014 | Published: 30 Apr 2013


Records management strategies to maintain regulatory compliance
sponsored by
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
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