Equivalence Studies - Validation Activities for several Identical Pieces of Equipment

C

cuteprettyone

#1
:bigwave:Hi,

I was wondering if anyone has developed an Equivalency procedure used during the execution or maintenance of validation activities for several identical pieces of equipment such as lathes, mills, etc.....

Do you believe if the variances of two identical pieces of equipment are equal or better than a "gold" standard then equivalency testing can be incorporated in validation activities?

:thanx:
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Leader
Super Moderator
#2
Re: Equivalence Studies - Validation Activities for several Identical Pieces of Equip

well since your posting in the FDA forum we should first understand that our 'beliefs' have little to do with acceptability to the FDA statisticians. Also, the FDA typically doesn't accept 'equivalence' as statistically we can't ever prove that. We can however demonstrate that no substantially important difference exists. This usually requires large-ish sample sizes. We must incorporate the Beta risk of missing a small difference D (where D is the acceptable difference between the two systems) for determinimg the sample size. Both the average and the variance are important. My organization will utilize matched pairs as often as possible to minimize teh sample size.
 
J

Juan Dude

#3
Re: Equivalence Studies - Validation Activities for several Identical Pieces of Equip

Validation in this case is the tool used to prove with objective evidence your belief that there is no difference between the equipment.

Best of luck.
 
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