Ouch?!??? [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2017-05-25 18:24 (2550 d 22:12 ago) – Posting: # 17419
Views: 28,786

Hi Hötzi,

I am not a WNL/Phoenix user, but if your post is correct then I imagine around 100 CROs as of today will need to change their software validation status from PQ'ed to "unknown" etc, contact the vendor, await a response and in the meantime do everything they can to study the potential impact on data generated (which they cannot necessarily do unless they have other 'validated' software that achieves the same)?
Only the software developer, who has the source, will be able to tell if there is a bug, and if there is, if the bug affects other models, and how/when. This is not good. Man, I don't even quite know what validated means anymore.

Pass or fail!

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