[Histonet] Validation Studies

[Liz Chlipala]

Schanudra

What we do on all of our major equipment for equipment validation such
as the tissue processor, slide stainer and our dako autostainer is we
perform an IOQ or an Installation/Operational Qualification Protocol. We
do this primarily to be able to run GLP studies on this equipment. Its
very detailed and goes over everything that a particular piece of
equipment should do and then verifiying that is does what it says it
will do.   The table of contents is listed below for the dako
autostainer:  As you can see it is quite detailed.  I'm not sure what is
required for JCAHO standards, but this is what we do for GLP compliance.

1.0	General Objective(s)	4
2.0	Scope	4
3.0	Acceptance Criteria and Expected Outcomes	4
4.0	System Description and General Information	4
5.0	IOQ Protocol Execution Procedures and Test Failure Handling
7
6.0	Related Documents	8
7.0	DAKO Autostainer Universal Staining System Installation /
Operational Qualification Test Cases	9
8.0	IOQ-1 Pre-requisite Documents Verification	10
9.0	IOQ-2 Operation and Maintenance Manuals Verification	13
10.0	IOQ-3 System Environment Verification	17
11.0	IOQ-4 Utilities Verification	22
12.0	IOQ-5 Major Components Verification	25
13.0	IOQ-6 Hardware Verification	30
14.0	IOQ-7 Software Verification	33
15.0	IOQ-8 System Operations and Functions Verification	36
16.0	Completion of Installation/Operational Qualification Tests
44
17.0	Signature Table	45
18.0	Attachments	46

Liz
 

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
P.O. Box 18592
Boulder, CO 80308
phone (303) 735-5001
fax (303) 735-3540
liz <@t> premierlab.com
www.premierlab.com
 
Ship to Address:
 
Premier Laboratory, LLC
University of Colorado at Boulder
MCDB, Room A3B40
Boulder, CO 80309

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of
Schaundra Walton
Sent: Thursday, March 27, 2008 12:46 PM
To: Histonet
Subject: [Histonet] Validation Studies

Dear Histonetters,
   
  We are looking at bringing in a Ventana Benchmark XT IHC stainer.  We
currently use the Ventana Nexus IHC stainer.  Has anyone else made this
transition or simply added a new IHC stainer lately?  How did you
validate the new equipment?  Is there a certain number of slides or
cases you had to run?  Any help would be much appreciated.
   
  Thanks,
   


Schaundra Walton BS HTL(ASCP)
Swedish American Hospital
1401 E. State St. 
Rockford, IL 61104
       
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