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FDA 21 CFR 11

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FDA 21 CFR 11Reports
 
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

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 - 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

Understanding Regulatory Implications for Better Data, Connectivity, and Reporting
sponsored by OpenText GXS
WHITE PAPER: Find out what you need to do to remain compliant and competitive during a time of change, and uncover the benefits of enhancing operational efficiencies for new regulatory requirements.
Posted: 16 Jun 2014 | Published: 30 Apr 2014

OpenText GXS

Biotechnology Company Automates Compliance, Delivers Cloud Services
sponsored by Hewlett-Packard Company
WHITE PAPER: Reduced provisioning from weeks to minutes.HP cloud and automation solutions helped a biotechnology company achieve a level of control that is unprecedented in its sector. Get the details by downloading and reading the case study.
Posted: 03 Sep 2014 | Published: 30 Jun 2014

Hewlett-Packard Company

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

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

Improved Scalability and Availability are the Keys to Better Storage Management
sponsored by EMC & Arrow
WHITE PAPER: This white paper highlights the benefits of scale-out NAS solution from EMC that can keep up with exponential data growth, increased regulations and compliance mandates. This solution provides the flexibility and availability that traditional storage approaches can't provide.
Posted: 22 Apr 2014 | Published: 28 Jun 2013

EMC & Arrow
 
 
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