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December 2003

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Subject:
From:
Jacqueline Hewitt <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 8 Dec 2003 21:09:01 -0500
Content-Type:
text/plain
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text/plain (179 lines)
The original print-out from the Vitek has always been the only true raw data as all stored results can be manipulated. We have not loaded the new compliant software as there is a glitch in it which BioMerieux is working on. I understand it is corrected and being reviewed and will be sent out early in the new year. The Vitek datatrac is a very useful tool for trending. We save not only all tests run on the Vitek but also enter IDs done by colonial appearance and Gram stain (genus only)on less critical samples. As all IDs are in the Vitek, we can trend all isolates from a variety of different samples. The critical factor is setting up DataTrac to give you the best trending capability for your needs
Jackie Hewitt, Luitpold Pharmaceuticals
----- Original Message -----
From: "Tirado, Wil" <[log in to unmask]>
Date: Monday, December 8, 2003 12:47 pm
Subject: Re: [PMFLIST] VITEK CFR 21, Part 11

> 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 
> simplydecide 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 
> guidelineswhich 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 
> validationpackage 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 [[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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> 
> Please take a second to visit our sponsors' web sites and say 
> thank you for their support of this service.
> AAI - http://www.aaiintl.com/Micro.htm
> Accugenix - http://www.accugenix.com/
> Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
> Microcheck - http://www.microcheck.com/
> MIDI, Inc. - http://www.midi-inc.com/
> Microbial ID, Inc. - http://www.microbialid.com/
> MicroTest World Class Services - http://www.microtestlabs.com/
> MIDI Labs, Inc. - http://www.midilabs.com/
> Millipore - http://www.millipore.com/
> NovaTek International - http://www.ntint.com
> Raven Biological Labs - http://www.ravenlabs.com
> Veltek Associates, Inc - http://www.sterile.com
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The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Microcheck - http://www.microcheck.com/
MIDI, Inc. - http://www.midi-inc.com/
Microbial ID, Inc. - http://www.microbialid.com/
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI Labs, Inc. - http://www.midilabs.com/
Millipore - http://www.millipore.com/
NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.com

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