In article <199611202235.RAA13345 at gate.cybernex.net>,
yersinia at GATE.CYBERNEX.NET (Yersinia) writes:
>>We use a Vitek too. When you say validation, do you mean the computer
>part or the cards? I can tell you about the cards (I'll ask about the
>computer if you want, though).
I think Daniel Larrimore is talking about the FDA IQ (installation
Qualification), OQ (operation Qualification), and PQ (performance
qualification) validation required on identification systems. My
protocol for the last system I validated was about 50 pages long and
included the entire system.
What you ( yersinia at GATE.CYBERNEX.NET (Yersinia)) are talking about is
only the day to day and batch to batch quality control of the Vitek. That
would definitely not satisfy an FDA investigator. They want to see a
protocol acceptance criteria, an SOP including how you maintain the
system, calibrate, and resolve discrepancies, etc. False or misleading
ID rate discovered during the validation protocol. The frequency of
re-validation. Not just simple daily QC.
Davin
Davin C. Enigl, MS-MEAS, President-Microbiologist
HACCP Validations-sm Hazard Analysis and Critical Control Points for the
Food, Cosmetic, Pharmaceutical, and Nutritional Supplement Industry
Voice: (916) 989-8264
Web site: http://members.aol.com/enigl/index.html
November 22, 1996
7:04 am
