<p class="MsoNormal"><span lang="EN-US">This
validation procedure embraces all computerized and automatized systems used by
process in the scope of Digitalis, including user interfaces and automated
processes for data collection, data management, user accounts management and
system administration.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The Digitalis
application of the system is composed of a core application, an intermediate
programming layer for specific adaptations, and a configuration depending on
the end user requirements. The intermediate programming layer and configuration
are not included in the scope of validation.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">This is
described in the user requirements specifications and in the detailed
functional specifications documents.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">It doesn’t
include:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Text
or spreadsheet documents without macros,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Software
used in processes outside scope: accounting, legal, interfaced software…<o:p></o:p></span></p><p>











</p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US" style="background:yellow;
mso-highlight:yellow;mso-ansi-language:EN-US">The IT infrastructure managed
through the xxx procedure (your procedure).</span><span lang="EN-US"> <o:p></o:p></span></p>