<p class="MsoNormal"><span lang="EN-US">Operational
qualification aims to ensure that every function of the computerized system is
working as expected.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The scope
of OQ testing includes, as applicable:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; 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">Functional
and performance requirements,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<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;
</span></span><!--[endif]--><span lang="EN-US">Verifying
software functions,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<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;
</span></span><!--[endif]--><span lang="EN-US">Security,
safety and privacy,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; 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">Non-functional
requirements, like<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<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;
</span></span><!--[endif]--><span lang="EN-US">Administration
functions,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<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;
</span></span><!--[endif]--><span lang="EN-US">Maintenance
functions,<o:p></o:p></span></p><p>















</p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<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;
</span></span><!--[endif]--><span lang="EN-US">21
Part 11 compliance.<o:p></o:p></span></p>