<p class="MsoNormal"><a name="_Hlk10032548"><span lang="EN-US">The risk assessment is focused on GxP and business risks. The assessment
is based on regulatory requirements, user requirements and derived functionalities.<o:p></o:p></span></a></p><p>



</p><p class="MsoNormal"><span lang="EN-US">Based on
GAMP5 classification DIGITALIS is a Category 4 system.<o:p></o:p></span></p>