8. Conclusion

The accuracy profile methodology has already been applied in a large number of applications (see the non-exhaustive list in the Need to know more section).

A number of conclusions can be drawn from these examples.

• The great generality of this approach. The list of methods that have been studied is already long: chromatography, spectroscopy, titrimetry, gravimetry, ELISA, PCR, microbiology, physics and so on.

• In very general terms, if we take the definition of validation, the proposed approach follows exactly this definition: 1) start from the objectives to be achieved in terms of acceptability limits; 2) collect actual evidence through experimental designs; 3) then examine it statistically and graphically to confirm or invalidate validity.

• The level-by-level profile...