Federal Register notice: May 10, 2007 (Volume 72, Number 90), “The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled Computerized Systems Used in Clinical Investigations, dated May 2007. This document provides to sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in clinical investigations. Because the source data in source documentation are necessary for the reconstruction and evaluation of the trial to determine the safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation, i.e., electronic records. This guidance supersedes the guidance entitled “Computerized Systems Used in Clinical Trials,” dated April 1999; finalizes the draft guidance of the same title dated September 2004; and supplements the guidance for industry entitled “Part 11, Electronic Records; Electronic Signatures–Scope and Application,” dated August 2003, and FDA’s international harmonization efforts when applying guidance to source data generated at clinical study sites.”