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Proof-of-concept clinical study.
Controlling the manufacture helps repeatability and hence quality of conformance.
Quality can be defined as "conformance to requirement" and/or "fitness for use" and/or "the degree of conformance to a standard" and/or "user satisfaction" ([23] p.51).
Performance testing--often referred to as 'beyond conformance testing' [3]--is an extension of conformance testing to a more sophisticated quantitative evaluation of commercial products.
Besides, within each level of conformance, different sublevels can be certified.
Meanwhile, Level of conformance with diagnostic guidelines, efficiency of diagnostic and treatment process, and treatment were measured as main outcome.
The method has been proven to be in conformance with 21CFR (Code of Federal Regulations) Part 11, which implies proof of reproducibility within a given error range.
The method has been proven to be in conformance with FDA-Guideline "Guidance for Industry - Bioanalytical Method Validation (May 2001"), which implies proof of reproducibility within a given error range.
The proof of everything.
Botswana is proof of it.
Absence is proof of presence.
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