<p class="MsoNormal"><span lang="EN-US">The purpose
of this Validation Plan (VP) is to define the strategy, activities,
deliverables and responsibilities to be performed for the validation of the
DIGITALIS system.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">Its goal is
to set the principles to:<o:p></o:p></span></p><ul style="margin-top:0cm" type="disc">
 <li class="MsoNormal"><span lang="EN-US">Bring evidences that involved processes
     are compliant with quality and regulatory requirements,<o:p></o:p></span></li>
 <li class="MsoNormal"><span lang="EN-US">Ensure the safety and integrity of
     critical data.<o:p></o:p></span></li>
</ul><p class="MsoNormal"><span lang="EN-US">The
objective of validation is to demonstrate with a high level of confidence that
the system DIGITALIS will operate correctly when used, in terms of the scope of
use described in user requirements specifications and detailed functional
specifications of the system. <o:p></o:p></span></p><p>







</p><p class="MsoNormal"><span lang="EN-US">The results
of the validation will be described in a Validation Report.<o:p></o:p></span></p>