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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.

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

C&J Energy: Going Public and Outgrowing Its Infrastructure
sponsored by Alert Logic
WHITE PAPER: This white paper describes how C&J Energy, an oilfield services firm, collaborated with Alert Logic in order to meet user needs and achieve SOX compliance quickly without compromising protected information or spending unnecessary time on installation and implementation.
Posted: 22 Oct 2014 | Published: 22 Oct 2014

Alert Logic

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

IBM

Email Security Checklist: Eight Steps for Healthcare Organizations
sponsored by Mimecast
WHITE PAPER: This white paper explains how you can embrace email as a core communication tool while still adhering to HIPAA guidelines.
Posted: 18 Dec 2014 | Published: 18 Dec 2014

Mimecast

Prevent Security Breaches with Continuous Monitoring
sponsored by Tenable Network Security
WHITE PAPER: This white paper discusses why defensive security products alone can't fully protect your enterprise from the types of security breaches that have made headlines in recent years, and proposes continuous monitoring as a potential solution.
Posted: 12 Nov 2014 | Published: 25 Jul 2014

Tenable Network Security

5 Steps to Reduce the Complexity of PCI Security Assessments
sponsored by Bit9, Inc.
WHITE PAPER: This helpful white paper outlines 5 steps for reducing the complexity of PCI assessments, lowering administration costs, and accelerating the attainment of a compliant and secure environment.
Posted: 16 Dec 2014 | Published: 16 Dec 2014

Bit9, Inc.

What Can You Do Differently to Guard Against Threats from Rapidly Evolving Mobile Malware?
sponsored by IBM
WHITE PAPER: Mobile security is about more than the device: It's also about protecting apps on the device. Learn how IBM can help.
Posted: 09 Oct 2014 | Published: 31 Jan 2014

IBM
 
 
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