When it comes to method criteria and validation procedures, I have spoken with countless lab directors, supervisors, auditors, consultants, etc. over the years and it amazes me how many insist that their way is “THE WAY”. I have seen this with validation reports, acceptance criteria, workflow procedures, etc. This despite many can’t even explain why they choose the criteria and procedures they do yet they insist others should follow their “THE WAY”. To make matters worse many of these different “WAYS” contradict each other. This leads to a wide range of issues including insufficient quality in an assay to the other end of the spectrum of overkill and time-wasting exercises that don’t contribute to increased value.
Each lab test must be considered for what the test is intended to achieve. The evaluation of a test used in a PK clinical trial may be different than a qualitative drug screen test. They are different tests with different objectives.
It would help the lab industry if more people stopped to ask questions like: What goal is the assay trying to accomplish? Who is the target audience? What criteria needs to be met to accomplish these goals? Have I met them? Good Science requires asking questions and trying to honestly answer them. - This is the Lab Way.
