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December 2003

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Subject:
From:
"Tirado, Wil" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 8 Dec 2003 12:47:52 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (120 lines)
Based on the revised guidelines (part 11) and on the extent in which the
software upgrade is limited to address only the part 11 issues, then you may
have some flexibility in your approach (adopting the upgrade, keeping the
previous version or installing the upgrade but still define the raw data as
your automatic print-out).  

If you want to continue to define the raw data as the automatic paper
print-out, the revised guidelines will support this approach provided that
you have adequate controls (by means o a SOP, etc.) to prevent using the
information that typically gets transferred to the hard disk (or simply
decide not to transfer the data).  The SOP should be very clear about this
issue and alert the analyst that under any circumstances they should use the
stored data as raw data.   

However, I must also mention, that I have seen at least one 483 citation
(can't remember where or which company) where an inspector had a different
perspective although I believe this was prior to the revised guidelines
which in my opinion are now very clear about this.

Installing the software upgrade and showing that it does not affect
functionality of the system while still defining the raw data as your paper
print-out should be simple and more of a IQ/OQ qualification excersise
(provided that the upgrade was limited to the part 11 issues and does not
affect functionality).  However, you may choose to store the data
electronically and use it as your raw data.  If you do so, you will need a
more complex approach to ensure that all the part 11 aspects are ok
(verification of audit trail capability, password protection, encryption,
etc).  In fact, bioMerieux was suppose to release an updated Validation
Package that will incorporate a step by step guidance about what to do if
you choose this approach.  However, for some reason this upgraded validation
package has not been released and can't comment on how they approach and how
adequate is their approach. 


Regards,

Wil Tirado


-----Original Message-----
From: Person, Jane [mailto:[log in to unmask]]
Sent: Friday, December 05, 2003 4:22 PM
To: [log in to unmask]
Subject: [PMFLIST] VITEK CFR 21, Part 11


I am currently writing procedures for validation and operation of the VITEK
32 System.  Recently, bioMérieux release an updated software version to
address CFR 21, Part 11 requirements.  I am curious to know if other
companies are utilizing this new feature.
I am also wondering if anyone is using the Data Trac to do trending analysis
or if results are deleted after the final identification has been made and
printed.  If data is saved in the database, what is considered the raw data
and how it is being handled.  

Jane Person
Senior Microbiologist
Solvay Pharmaceutical, Inc.
(218) 634-3552
Fax (218) 634-3625


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the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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Accugenix - http://www.accugenix.com/
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NovaTek International - http://www.ntint.com
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Veltek Associates, Inc - http://www.sterile.com

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