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December 2003

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Subject:
From:
"Hatton, Lynne F" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 8 Dec 2003 16:32:21 -0000
Content-Type:
text/plain
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text/plain (102 lines)
We have a Vitek 120 and have not yet had sight of the new software update.
We do not use Data Trac for trending as we do not save data to the database
- because of the CFR21 Part 11 requirements.  Our raw data is the result
printout.

> Lynne
> 
> Lynne Hatton
> Microbiology Team Co-ordinator
> *   +44 (0)1833 692766 (7745 2766)
> Fax: +44 (0)1833 692774 (7745 2774)
> *     19, BQG, L Block
> e-mail -:  [log in to unmask]
> 
> 
> -----Original Message-----
> From: Person, Jane [SMTP:[log in to unmask]]
> Sent: 05 December 2003 21:22
> 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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> Veltek Associates, Inc - http://www.sterile.com

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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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