Hello all,
This is a slightly strange one.
I need to convince a community of practice (field biologists) that they need to validate their tools and methods before they use them to generate results that are used as the basis for important management decisions.
While QC and validation have penetrated to the benches in biochemistry and microbiology labs, they are completely foreign to field biologists, for reasons that I will not burden you with here.
What I need is a basic introduction to QC and validation that is not specific to the hard sciences (physics and chemistry), and that sets out the fundamental reasons why knowing that a tool and a method work properly are essential steps in doing good science and generating results that can be relied on.
I have googled all the combinations of validation, QC, fit for purpose, etc etc that I can think of, and everything I find is too specific to particular applications - I need something that sets out the basic need for validation in general. Peer reviewed or a standard textbook is preferred, but anything clearly written will be a help.
Thanks.
Peter
Mr. Apps,
The term 'quality control in research' is how to say.....very dispersive term. Accounting for the fact that curently even there is sport science.
There are no appropriate texts! ICH validation guidelines apply to pharmaceuticals and biopharmaceuticals. With small molecules it has been relatively easy to validate a method but stem cells will be very hard. Is a recovery of 50% for a fluorescent antigen technique appropriate?
The 'validation biologist' will have to demonstrate that the method is consistent and reliable. This will mean setting the appropriate and relevant acceptance criteria or specifications.
Bruce Neagle I was pretty sure that there was nothing aimed at biologists, but a general text extolling the virtues of validation without reference to a specific field would also serve my purpose.
Have you given any thought to "Measuring behaviour" by Martin and Bateson? It is pretty basic, but covers many aspects such as validity, reliability, sampling etc. Maybe this would help for a start...
Thanks Rafal - I'll see if I can get a copy, I don't have access to an academic library.
The AOAC had a text on statistics. Maybe they have something on a consistent and reliable process. Validation (as I recall) was derived from SPC (statistical process control).
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