[Histonet] Equipment Validation

[mark.lewis <@t> thermo.com]

Good morning everyone.

I have a question concerning equipment validation.

We recently had a customer that said they were cited during an inspection
for not having a record of their new equipment being validated.
I am assume that the validation of the equipment means that they should
have run a parallel test with the new and "old" piece of equipment to
verify that it indeed performs as it should. The customer felt it was our
responsibility to do the validation testing in their lab for the equipment.
Does anyone have some more insight or protocols as to  what equipment
validation documentation is required of inspecting agencies like Joint
Commission ?

I appreciate your input.

Have a Blessed Day !


Best regards,

Mark

Mark Lewis
Product Specialist
Anatomical Pathology
Clinical Diagnostics
Thermo Electron Corporation
(412) 747-4013
(412) 788-1097
E-mail: mark.lewis <@t> thermo.com