<p class="MsoNormal"><span lang="EN-US">Reports are
required to summarize each of the qualification phases of the validation
project.&nbsp; <o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">All
qualification reports must address the following:<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">An
overall summary of the results,<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">Inclusion
or reference of the location of the qualification documentation (approved and executed
tests protocols),<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">Discussion
of all deviations, corrective actions, and resulting changes (especially bug
fixes between IQ and OQ or OQ and PQ)<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">A
conclusion that includes conditions for use of the system.<o:p></o:p></span></p>