Re: FDA Regulation and cytometry

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Dear all,
I am using the FACSCalibur system in the research and development stage of
our product. We want to use the system for performing Quality Control test
during our clinical trials. In order to do that we need to validate the
system.

I would like to inquire if any one have knowledge of any validation package
for the FACSCalibur system that includes Installation Qualification,
Operation Qualification and software validation. Would this system comply
with 21CFR11 (electronic records; electronic signatures)?
Do you have any other information about setting up a flow cytometry under
GMP/FDA regulation?

Thank you for your help
Kind Regards
Lea


Lea Reich, Ph.D.
QC Manager
Proneuron Biotechnologies (www.proneuron.com)
Tel: +972 8 9409550
Fax: +972 8 9409560

• Next message: Wayne A. C. Harris: "Here I am at the alter of FLOW"
• Previous message: Ann Atzberger: "discordant results from flow and microscopy"
• In reply to: Howard Shapiro: "Re: Luminex?"
• Next in thread: Betsy M. Ohlsson-Wilhelm, Ph.D.: "Re: FDA Regulation and cytometry"
• Maybe reply: Betsy M. Ohlsson-Wilhelm, Ph.D.: "Re: FDA Regulation and cytometry"
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