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<p class="MsoNormal">Hi Valerie,<o:p></o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal">The verification plan in the CAPA lists the things that are provided as “objective evidence”. Typically, each item is made into a PDF and given to the initiator to review. Once accepted, I will combine the evidence and the CAPA report into
a single PDF record. Here are your verification plan steps, with my comments.<o:p></o:p></p>
<p class="MsoNormal"><o:p></o:p></p>
<p class="MsoListParagraphCxSpFirst" style="text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="mso-list:Ignore">1.<span style="font:7.0pt "Times New Roman"">
</span></span><![endif]>Verify the new Administrative Panel is created and handles re-opening of Traveler Records.<o:p></o:p></p>
<p class="MsoListParagraphCxSpMiddle" style="margin-left:1.0in;mso-add-space:auto;text-indent:-.25in;mso-list:l0 level2 lfo1">
<![if !supportLists]><span style="mso-list:Ignore">a.<span style="font:7.0pt "Times New Roman"">
</span></span><![endif]>I think your screen shot shows a changed traveler, but not the Administrative Panel.<o:p></o:p></p>
<p class="MsoListParagraphCxSpMiddle" style="text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="mso-list:Ignore">2.<span style="font:7.0pt "Times New Roman"">
</span></span><![endif]>Verify all Pansophy Database Administrators have been trained in the only approved method for re-opening Traveler Records.<o:p></o:p></p>
<p class="MsoListParagraphCxSpMiddle" style="margin-left:1.0in;mso-add-space:auto;text-indent:-.25in;mso-list:l0 level2 lfo1">
<![if !supportLists]><span style="mso-list:Ignore">a.<span style="font:7.0pt "Times New Roman"">
</span></span><![endif]>An email or meeting minutes that show the other DBAs are informed/trained on this new feature is fine.<o:p></o:p></p>
<p class="MsoListParagraphCxSpMiddle" style="text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="mso-list:Ignore">3.<span style="font:7.0pt "Times New Roman"">
</span></span><![endif]>Validate the Database no longer contains "re-opened" travelers without annotations of whom and date.<o:p></o:p></p>
<p class="MsoListParagraphCxSpLast" style="margin-left:1.0in;mso-add-space:auto;text-indent:-.25in;mso-list:l0 level2 lfo1">
<![if !supportLists]><span style="mso-list:Ignore">a.<span style="font:7.0pt "Times New Roman"">
</span></span><![endif]>I think your screen shot shows a corrected record, which may satisfy this item. However, this is phrased in a way that you need to prove a negative so I can’t tell.<o:p></o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal">Before you do anything with the items listed above, I need to catch up on the CAPA form. The most recent version of the CAPA-002 file I have doesn’t have the verification plan listed. The next step is for me to accept the corrective actions
and verification plan and note that on the CAPA form. If I did this, I don’t recall and couldn’t find any file or email about it. I should have followed up with you sooner.<o:p></o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal">Let’s chat tomorrow to confirm a few details and I think we can close it all out. Thanks,<o:p></o:p></p>
<p class="MsoNormal">Jacob<o:p></o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal"><b>From:</b> Valerie Bookwalter <bookwalt@jlab.org> <br>
<b>Sent:</b> Tuesday, May 31, 2022 2:51 PM<br>
<b>To:</b> Jacob Harris <jharris@jlab.org><br>
<b>Cc:</b> E. Anne McEwen <mcewen@jlab.org>; Ashley Anderson Mitchell <ashleya@jlab.org>; pansophy <pansophy@jlab.org><br>
<b>Subject:</b> CAPA-002 how to complete?<o:p></o:p></p>
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<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><span style="font-size:14.0pt">Jacob,<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">For my CAPA-002 against Record annotation when modified...<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">The Admin Page for opening/closing travelers has been modified to obsolete and old record and create a new one thereby annotating the modification.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">This is a snapshot of the database and how it looks when a record is modified.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">How do I complete this CAPA?<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">Valerie<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt"><o:p> </o:p></span></p>
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<p class="MsoNormal"><span style="font-size:14.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">Valerie Bookwalter<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">Jefferson Lab, SRF Department<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">Pansophy Team<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">1-757-269-5802 (OFFICE – currently working offsite)<o:p></o:p></span></p>
<p class="MsoNormal"><o:p> </o:p></p>
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