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FDA 21 CFR 11

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FDA 21 CFR 11Reports
 
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

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

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

Case Study - Transform Medical
sponsored by Nimble Storage
WHITE PAPER: Cosmetic surgery company transforms its storage and back-up infrastructure to comply with pending regulations and enhance patient safety.
Posted: 13 Aug 2014 | Published: 31 Jan 2014

Nimble Storage

One Easily Avoidable Pitfall in Your eDiscovery and Compliance Strategy
sponsored by CommVault Systems, Inc.
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

CommVault Systems, Inc.

Automate, Monitor, and Improve Your Compliance Procedures
sponsored by Interneer, Inc.
WHITE PAPER: This white paper explores the benefits of automating compliance procedures to free up employee resources and ensure that your organization is ready for an audit. It also highlights a solution that delivers this automation as well as monitoring capabilities.
Posted: 17 Jul 2014 | Published: 17 Jul 2014

Interneer, Inc.

Core HR Kit: Cut costs, engage your people, and ensure compliance
sponsored by SuccessFactors
WHITE PAPER: This resource offers insight to help you choose an effective core HR system. Read on to discover key benefits of the right tool and learn how you can get started today.
Posted: 04 Mar 2014 | Published: 04 Mar 2014

SuccessFactors

Creating an Enterprise Mobile Management Regulated Solution for BlackBerry Enterprise Service 10
sponsored by BlackBerry
WEBCAST: This exclusive resource examines the enhancements that have been made in to BlackBerry ® Enterprise Service 10 and how it can support your organization's mobile needs in the regulated market in terms of security, mobile auditing, archiving and forensics.
Posted: 14 Nov 2013 | Premiered: Nov 14, 2013

BlackBerry
 
 
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