The regulator has outlined the requirements for method validation in the codes. This guidance has been produced to provide background information to the codes and to assist in the implementation of its requirements.
This guidance adopts a descriptive rather than a prescriptive style, although it does contain some lists of things that it might be wise to consider when formulating plans. It is accepted that there may be other ways of achieving the same goals. It is implicit that a departure from the guidance may be entirely acceptable or even advisable if alternative approaches can give the same level of assurance in a more expedient way.