software: NCA not validated [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2019-02-16 12:59  – Posting: # 19928
Views: 2,650

Hi Nastia,

» […] it turns out that in some rare extreme cases it is worth to think about alternative approaches. Would it be accepted?

As I said numerous times – if described in the protocol – yes.

» How to be sure that the method stated in SAP would work better than PHX algo? Is it possible to explain in the report any disagreement with PHX output?

Good questions. No software is validated when it comes to NCA. Assessors/inspectors are you aware of it? See my attempt there.
For years the NCA Consortium is struggling to come up with sumfink. You have to apply for membership; interesting enough the majority of members are coming from originators or the academia. The task turned out to be rather difficult…

Cheers,
Helmut Schütz
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