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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

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

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.

The Collaborative Data Privacy Handbook
sponsored by IntraLinks, Inc
WHITE PAPER: As more organizations share sensitive data, the risk of leak or theft increases.  This white paper outlines six steps to improving data privacy and sharing principles and preventing regulatory and market sanctions.
Posted: 13 May 2015 | Published: 10 Dec 2014

IntraLinks, Inc

Gartner Report: New CIO Responsibilities in a Digital Business World
sponsored by Mendix
ANALYST REPORT: This Gartner report divulges findings from the latest research on how CIOs are staking out their digital leadership roles, for which one size doesn't fit all. Read on to learn experts' recommendations for clarifying CIOs' new set of responsibilities for the modern era of IT.
Posted: 30 Jul 2015 | Published: 28 May 2015


Four steps to ensure IT investments benefit regulatory compliance
sponsored by Hewlett-Packard Company
EGUIDE: In this expert e-guide, discover how companies can ensure new IT investments meet the business's regulatory needs in four simple steps.
Posted: 01 Oct 2014 | Published: 01 Oct 2014

Hewlett-Packard Company

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


Achieving Data Security and Compliance in the Healthcare Industry
sponsored by IBM
VIDEO: In this video, Mark Starry, Director of Enterprise Architecture and Security at Capital Region Health Care in central New Hampshire, discusses the technology they leveraged to achieve total network visibility and cost-effectively achieve compliance with security requirements.
Posted: 30 Jan 2015 | Premiered: 11 Jul 2012


Simple Strategies for BYOD Compliance
sponsored by CDW Corporation
EGUIDE: This expert e-guide explains how enterprise app stores can help enhance software license compliance and asset management by giving organizations better insight into employee-owned devices. Also, discover strategies to solve the compliance and management issues brought on by BYOD and mobile cloud applications.
Posted: 06 Mar 2014 | Published: 06 Mar 2014

CDW Corporation
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