Quality assurance implications for computerized systems following the Able Laboratories FDA Inspection

Abstract

The quality assurance implications for hybrid systems (electronic records with handwritten signatures on the paper copies) following an inspection of a computerized system by the United States Food and Drug Administration (FDA) are explored. The major compliance problem occurred because the paper copies differed, sometime radically, from the electronic records contained within a chromatography data system. These non-compliances ultimately caused the inspected company to go bankrupt. Copyright © 2006 John Wiley & Sons, Ltd.