<p class="MsoNormal"><span lang="EN-US">The
validation strategy consists in the validation phases:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" style="margin-top:4.0pt;margin-right:0cm;
margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level1 lfo1"><!--[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]--><b><span lang="EN-US">Analysis and Design:<o:p></o:p></span></b></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:4.0pt;margin-right:0cm;
margin-bottom:0cm;margin-left:72.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level2 lfo1"><!--[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]--><b><span lang="EN-US">User Requirements Specifications
(URS): </span></b><span lang="EN-US">it describes
the business needs for what users require from the system.<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:72.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level2 lfo1"><!--[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]--><b><span lang="EN-US">Functional Specification (FS):</span></b><span lang="EN-US"> it specifies the functions that a
system or component must perform and that answers needs from the URS.<b><o:p></o:p></b></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:72.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level2 lfo1"><!--[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]--><b><span lang="EN-US">Validation Plan (VP): </span></b><span lang="EN-US">it defines the scope and goals of a
validation project.<b><o:p></o:p></b></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level1 lfo1"><!--[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]--><b><span lang="EN-US">Installation Qualification (IQ):</span></b><span lang="EN-US"> it describes the process that is to
be followed when installing the system in an environment. This environment may
be a testing, validation, or production environment. IQ represents the
controls, instructions and verification steps of the successful installation
into the new environment.<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level1 lfo1"><!--[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]--><b><span lang="EN-US">Operational Qualification (OQ):</span></b><span lang="EN-US"> it includes functionality test
steps, test results, test reports and any testing problem reports.<o:p></o:p></span></p><p class="MsoListParagraphCxSpLast" style="margin-top:0cm;margin-right:0cm;
margin-bottom:12.0pt;margin-left:36.0pt;mso-add-space:auto;text-indent:-18.0pt;
mso-list:l0 level1 lfo1"><!--[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]--><b><span lang="EN-US">Performance Qualification (PQ):</span></b><span lang="EN-US"> It is a high-level testing based on
a routine use workflow. It allows to verify that the procedures and
computerized system work together and that routine users (with routine access
levels) can actually operate the system in a compliant manner. <o:p></o:p></span></p><p>















</p><p class="MsoNormal" style="margin-top:4.0pt;margin-right:0cm;margin-bottom:12.0pt;
margin-left:0cm"><span lang="EN-US">Qualification
is a systematic way of defining and verifying that the system is developed and
installed in accordance with its specifications and is fit for purpose.<o:p></o:p></span></p>