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FDA Compliance

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ALSO CALLED: FDA 21 CFR 11
DEFINITION: Compliance to FDA regulations.
FDA Compliance Reports
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5 Minutes with Propel: Integrated Customer Complaint Process
sponsored by PropelPLM
VIDEO: No company likes getting customer complaints, but in the medical devices industry, companies need to ensure they have an effective and auditable way for managing complaints. Download this video to uncover a modern way for handling customer complaints by integrating CRM, PLM, and QMS.
Posted: 18 Feb 2019 | Premiered: 30 Jun 2018

PropelPLM

Case Study: Yukon Medical + Propel
sponsored by PropelPLM
CASE STUDY: In this case study, uncover how a product lifecycle management (PLM) and improved quality management system (QMS) from Propel helped Yukon Medical manage their training process and scale to fit their current—and future—business goals. Download now to discover how Yukon Medical succeeded by switching their legacy systems to Propel.
Posted: 13 Feb 2019 | Published: 31 Dec 2018

PropelPLM

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
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