We perform our entire validation process as a new piece of equipment. Our validation protocols are quite extensive, up to about 85 pages long on each piece of major equipment, at least that's what it was for our new prisma stainer and glass coverslipper. We perform an installation/operational qualification protocol or an IOQ. If we move the instrument we also do the same thing, we already have the protocol written which takes most of the time we just execute it again. We are a GLP lab so we work off a Validation Master Plan that basically tells us how we are going to validate each piece of equipment in the lab.
Liz Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC Manager Premier Laboratory, LLC PO Box 18592 Boulder, Colorado 80308 office (303) 682-3949 fax (303) 682-9060 www.premierlab.com Ship to Address: 1567 Skyway Drive, Unit E Longmont, Colorado 80504 -----Original Message----- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Laurie Colbert Sent: Wednesday, May 19, 2010 9:00 AM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] IHC Validation on new instrument What do others do when validating a new model of a piece of equipment - same manufacturer, same basic staining process, but an updated version of the equipment? I've been told the protocols should be the same and that we only need to run three controls with three different but similar protocols to determine what looks best. Do you all think that is thorough enough, or would you run actual patient cases and compare old and new equipment? I don't see where the CAP checklist refers to new equipment - just new antibodies and new antibody lots. Laurie Colbert _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet