Ok, can some Doper working in the industrial/chemical world define “validation” or “process validation” for me? Is this equivalent to writing, reviewing and/or revising Standard Operating Procedures (SOPs)? Can someone please fill me in on this?
Thanx!
I’m a chemist.
The context in which I use it refers to the strength or quality of the data; that is, how can it be demonstrated that a piece of data is genuine and represents accurately that which it is trying to quantify - instead of some happy accident that coincidently appears to be a genuine number.
This means that there’s a lot of documentation, well-defined routines (SOPs), and many layers of checks - checks put into the system along with the sample, more checks after the sample is measured, and even more checks to compare new data against old data, and checks to make sure the thoroughness of all the checking routines was adequate.
This speaks nothing of the checks that make sure the analytical equipment is working as it should, so as not to throw off all your checks along with the data being acquired which actually pays the bills.
If you give me something more specific to work with, I’ll try to address it.