[Pansophy] CAPA-002 how to complete?

[Jacob Harris]

Hi Valerie,

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.

1.    Verify the new Administrative Panel is created and handles re-opening of Traveler Records.

a.    I think your screen shot shows a changed traveler, but not the Administrative Panel.

2.    Verify all Pansophy Database Administrators have been trained in the only approved method for re-opening Traveler Records.

a.    An email or meeting minutes that show the other DBAs are informed/trained on this new feature is fine.

3.    Validate the Database no longer contains "re-opened" travelers without annotations of whom and date.

a.    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.

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.

Let's chat tomorrow to confirm a few details and I think we can close it all out. Thanks,
Jacob

From: Valerie Bookwalter <bookwalt at jlab.org>
Sent: Tuesday, May 31, 2022 2:51 PM
To: Jacob Harris <jharris at jlab.org>
Cc: E. Anne McEwen <mcewen at jlab.org>; Ashley Anderson Mitchell <ashleya at jlab.org>; pansophy <pansophy at jlab.org>
Subject: CAPA-002 how to complete?

Jacob,

For my CAPA-002 against Record annotation when modified...
The Admin Page for opening/closing travelers has been modified to obsolete and old record and create a new one thereby annotating the modification.
This is a snapshot of the database and how it looks when a record is modified.
How do I complete this CAPA?

Valerie


[cid:image001.png at 01D87515.ECE89C60][cid:image002.jpg at 01D87515.ECE89C60]

Valerie Bookwalter
Jefferson Lab, SRF Department
Pansophy Team
1-757-269-5802 (OFFICE - currently working offsite)

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