Setting up a new flow facility

From: Darcie Tilly (DTilly@vical.com)
Date: Thu May 23 2002 - 13:45:52 EST


Hi,
Our company recently acquired a FACS Calibur, and we are at the stage where it will
soon be open for general use by people within the company.  We are looking into
acquiring a program (such as FileGuard) that will limit the users of the machine to
those individuals whom have a log-in ID and password, and would record which users
had logged in and for how long.  Are there alternatives to FileGuard?  Also if anyone
has expertise on 21CFR part 11compliance (our machine will need to be run under GLP
and perhaps in the future GMP guidelines) with relationship to flow data  I'd greatly
appreciate any sort of advice, or any general  insight on setting up a Flow Cytometry
facility in general. (Does anyone have a good, basic training program for getting new
users trained to run the machine?  The group of us that are the "operators" would like
to have a standard training protocol/ and rules of operation in place BEFORE we open
the machine up for general use, but since we've not run a flow facility before we do
not have a template to build from and cannot forsee what problems we want to avoid).

Thanks, and as I mentioned before ANY advice would be appreciated.
Darcie Tilly
Vical, Inc



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