<p class="MsoNormal"><span lang="EN-US">Digitalis
is an EDC system, a computerized system designed for the collection of clinical
data in electronic format<o:p></o:p></span></p><p>

</p><p class="MsoNormal"><span lang="EN-US">This
document describes the different validation steps related to Digitalis® as an
EDC system that complies with 21 CFR 11, ICH GCP guidelines and is consistent
with FDA guidance on electronic systems used in clinical trials and abide CDISC
standards.<o:p></o:p></span></p>