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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
Risk Management for Medical Devices
sponsored by Symantec & Intuitive
WHITE PAPER: This white paper reviews the regulations and challenges surrounding medical device and data security and how to take control of risk management.
Posted: 29 Oct 2015 | Published: 07 Oct 2015

Symantec & Intuitive

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

One Easily Avoidable Pitfall in Your eDiscovery and Compliance Strategy
sponsored by Commvault
WHITE PAPER: This white paper explains the challenges of big data and highlights one common pitfall organizations fall into when dealing with their eDiscovery and Compliance strategy. It also highlights how a solution from CommVault can help avoid this pitfall by delivering searchable endpoint data for more comprehensive searches.
Posted: 28 Apr 2014 | Published: 28 Apr 2014


Intralinks VIA™ for Managing Regulatory Examinations
sponsored by IntraLinks, Inc
WHITE PAPER: Access this resource to learn about the leading vendor in the enterprise collaboration and social software market.
Posted: 30 Apr 2015 | Published: 30 Apr 2015

IntraLinks, Inc

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


Security Intelligence Is the Smart Way to Keep the Cloud Safe
sponsored by IBM
WHITE PAPER: Find out how an integrated IBM suite of intelligence solutions consolidates and analyzes data from across the cloud to provide organizations with visibility and control, to help better secure cloud environments.
Posted: 08 Oct 2014 | Published: 31 Oct 2013


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

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