<p class="MsoNormal"><span lang="EN-US">A
Validation Report is required to verify the completion of all activities
required by the validation protocol.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The
validation report must address the following:<o:p></o:p></span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt 45.4pt; text-indent: -22.7pt;"><!--[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;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">An
overall summary of the validation project,<o:p></o:p></span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt 45.4pt; text-indent: -22.7pt;"><!--[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;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">A
list of all deliverables generated as per the Validation Plan and their
location,<o:p></o:p></span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt 45.4pt; text-indent: -22.7pt;"><!--[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;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Any
deviation from the Validation Plan with justification,<o:p></o:p></span></p><p>









</p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt 45.4pt; text-indent: -22.7pt;"><!--[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;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">A
clear conclusion based on the acceptance criteria here below indicating whether
or not the system is suitable for use in routine operations.<o:p></o:p></span></p>