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FDA 21 CFR 11

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FDA 21 CFR 11 Reports
 
Social Media Risks and Benefits for the Pharmaceutical Industry
sponsored by Actiance
WHITE PAPER: This white paper discusses the push and pull that pharmaceutical companies feel between utilizing social networks to improve business results, and meeting the regulatory requirements of agencies like the FDA for the use of these networks.
Posted: 17 Feb 2015 | Published: 11 Jul 2014

Actiance

Collaboration and Social Media in the Pharmaceutical Industry
sponsored by Actiance
WHITE PAPER: This white paper is an excellent resource for pharmaceutical companies weighing the benefits and risks of social media. Read on to learn what the pharmaceutical industry's regulatory landscape looks like, and which concerns you should be aware of from a legal perspective.
Posted: 17 Feb 2015 | Published: 11 Jul 2014

Actiance

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

Maximizing Profitability and Customer Service in Banking with Automated Financial Transactions
sponsored by IBM
ANALYST REPORT: Access this report today to learn how a single, central, open architecture solution that integrates disparate systems can improve financial institutions' profit margins, compliance, and customer satisfaction.
Posted: 26 Jan 2015 | Published: 21 Jul 2014

IBM

Healthcare Email Management: Balancing Security, Compliance, and Cost
sponsored by Mimecast
WHITE PAPER: This white paper discusses a number of email management challenges facing healthcare CIOs, including HITECH and HIPAA compliance, budget constraints, cloud-based email and collaboration technologies, and data security.
Posted: 17 Dec 2014 | Published: 17 Dec 2014

Mimecast

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

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

IBM
 
 
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