Date: Thu Jun 26 2008 - 09:34:24 EDT
The big ticket item here in the states is the FDA's 21st Code of Federal Regulations (CFR), part 11. This entails computer/system validation to ensure the integrity of electronic data. I'm not sure if the Canadian Guidelines have something similar for electronic data capture, but that should be the only hurdle. As far as a Method Validation goes...if you run your protocol - no matter how many colors - and perform a comparison to microscopy or other gold standard technique for your endpoint, as long as the governing scientific body of your lab signs off on it, you should be good to go. I had IT QC, Management, and Authors/testers sign off on my documents, with QA giving the final approval. I've validated 2 flows, a BD Calibur, and a BD Canto, and most of the validation work is spend on the electronic data / system security portions. Your QA department should have some sort of format for dealing with GLP automation - unless the flow is their first piece of equipment that will generate data. Just so you know, unless you are going to submit the data for an IND or NDA, I do not believe that you need to go the FDA GLP 21 CFR part 11 route. Here's a website though if it will help: http://www.21cfrpart11.com/ <http://www.21cfrpart11.com/> Also, if you share details of the method you're validating, I'm sure that some of the experts on this distribution list will have some pointers on which antibodies / gating logic is more appropriate. Good Luck! Dan _________________________ Technical Resource Specialist Genetic Toxicology Department Covance Laboratories, Vienna, VA 703-245-2200 x5136 (Office) x5589 (Lab) _____ From: Cythéris - Stéphanie BEQ [mailto:sbeq@cytheris.com] Sent: Tuesday, June 24, 2008 12:36 PM To: cyto-inbox Subject: Validation report for multiple staining Dear flowers, I have just join a private company (I was previously working in the academic) and one of my topics is to install flow cytometry (not a problem for research use) by Quality Assurance (that is the problem) and I'm not familiar with QA. I have already found the Canadian Guideline for flow cytometry (2001) and the H42-A2 from NCCLS on the web and the daily/monthly QC of the instrument itself should not represent a big difficulty, but the validation of staining, antibodies panel, compensation, multicolor analysis, gating, reproducibility, what kind of calibrator should I choose.....remains unclear for me. Is anybody having a two (or more of course!) colors staining validation report (or validation plan)? It could be really helpful for me to adapt it and develop it for an 8 colors panel. Does more recent guidelines exist (FDA or CDC or else?) ? Thank you for your help. Best regards, Stéphanie Beq ******************************************** BEQ Stephanie Immunological Studies Manager cid:image001.gif@01C8B782.D5D90420 CYTHERIS S.A. Technopolis, 175 rue Jean-Jacques Rousseau 92130 ISSY-LES-MOULINEAUX, France sbeq@cytheris.com <mailto:bassouline@cytheris.com> www.cytheris.com Tél: 33(0)1 5888 3819 fax 33(0)1 4644 4446 STATEMENT OF CONFIDENTIALITY The information contained in this electronic message and any attachments to this message are intended for the exclusive use of the addressees and may contain confidential or privileged information. If you are not the intended recipient, please notify "Cytheris" immediately at either (33)15888 3800 or at info@cytheris.com <mailto:info@cytheris.com> , and destroy all copies of this message and any attachments. ----------------------------------------------------- Confidentiality Notice: This e-mail transmission may contain confidential or legally privileged information that is intended only for the individual or entity named in the e-mail address. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance upon the contents of this e-mail is strictly prohibited. If you have received this e-mail transmission in error, please reply to the sender, so that we can arrange for proper delivery, and then please delete the message from your inbox. Thank you.
