By Topic

FDA-regulated validation in clinical and nonclinical environments (Regulatory Affairs)

Sign In

Cookies must be enabled to login.After enabling cookies , please use refresh or reload or ctrl+f5 on the browser for the login options.

Formats Non-Member Member
$33 $13
Learn how you can qualify for the best price for this item!
Become an IEEE Member or Subscribe to
IEEE Xplore for exclusive pricing!
close button

puzzle piece

IEEE membership options for an individual and IEEE Xplore subscriptions for an organization offer the most affordable access to essential journal articles, conference papers, standards, eBooks, and eLearning courses.

Learn more about:

IEEE membership

IEEE Xplore subscriptions

The Food and Drug Administration (FDA) governs the activities of medical and pharmaceutical research and healthcare organizations through regulations including, but not limited to, good laboratory practices (GLPs), current good manufacturing practices (CGMPs), good clinical practices (GCPs), and electronic records and electronic signatures (ERESs). These good practices and ERESs cite various requirements that comprise "validation". These regulations cover both the clinical and nonclinical environments. The FDA requires many different types of validation, such as methods and data validations. This article presents an overview of two validation types: a system validation and computer system validation (CSV)

Published in:

IEEE Engineering in Medicine and Biology Magazine  (Volume:26 ,  Issue: 1 )