Method Comparison Design Onput Sample Range Requirement

[scda0505]

First post, Hi y'all

So when writing a design input for a method comparison requirement would you include the sample range in that requirement? Or would you include it in the SOP?

Here is a simple example using slope. (I am not including other requirements and keeping this ambigious to make this example simple)

Design input - method comparison
Reference method: Predicate device
Acceptance criteria: Slope of 1.0 +/- 0.1

vs

Design input - method comparison
Reference method: Predicate device
Acceptance criteria: Slope of 1.0 +/- 0.1
Sample Range: Sample doses must span the range of 3 to 400 units


What is your opinion? Include the sample range in the requirement or leave it out since the SOP has the sample range information in it.


Cheers

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[scda0505]

I apologize for the typo in the title of this thread. "Onput" should be "Input".

 

[scda0505]

Well, I wrote this nice hypothetical that gave better insight to my question but it deleted when I accidently hit the mouse pad and then "backspace" sending my browser back a page. Lesson learned. I will attempt to rewrite it, later today, in a word document.