21 CFR Part 11: Electronic records. An interactive voice response system. Case study for success

Abstract

A large full-service clinical research organization in the US needed to replace their legacy interactive voice response system which did not provide 21 CFR Part 11 compliant audit trails. They chose to custom-build the new software using C++ component architecture, extensible Markup Language (XML), Hypertext Markup Language (HTML), and Microsoft web telephony engine. The case study described in this article illustrates that when systems developers read, study, understand, and embrace 21 CFR Part 11 before designing and validating their product, the regulations are easily met. Copyright © 2002 John Wiley & Sons, Ltd.