ABSTRACT

Since 2004, inspection trends worldwide have focused on issues related to the integrity of e-records with the issue also coming to prominence in the United States since 2007 (Figure 2.1).

Three major cases on e-records integrity were reported in the United States in 2006 and 2007: Able Laboratories (2006), Leiner Healthcare Products (2007), and Actavis Totowa (2007).