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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
 
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

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: 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

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

IBM

IDC Flash: IBM Releases IAM for Mobile, Cloud and Enterprise
sponsored by IBM
WHITE PAPER: Gain insights into IBM's threat-aware IAM solutions focused on enabling identity as the new security perimeter.
Posted: 09 Oct 2014 | Published: 29 Nov 2013

IBM

Demand More From Your Data Center Environment
sponsored by Iron Mountain
WHITE PAPER: This resource introduces a colocation strategy that offers more than just space and power to help you optimize your data center operations, achieve compliant IT security, and more.
Posted: 28 Jan 2014 | Published: 31 Dec 2013

Iron Mountain

Executive Guide to SYSPRO Security for Auditing Assurance and Control
sponsored by SYSPRO
WHITE PAPER: This white paper introduces an enterprise resource planning (ERP) system with the governance, risk, and compliance functionality you need to satisfy regulatory requirements and fuel security success.
Posted: 03 Apr 2014 | Published: 31 Dec 2013

SYSPRO

Business Driven Governance: Managing Policies for Data Retention
sponsored by IBM
WHITE PAPER: This resource explains how you can establish and manage an overall data retention strategy through information governance and database archiving policies.
Posted: 27 Feb 2014 | Published: 31 Aug 2013

IBM
 
 
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