Bioequivalence and Bioavailability Forum

Hi again,

❝ Yes, how much is possible and what are the efforts? Example: Phoenix’s validation suite costs more than the software itself. If you test all components (NCA, BE, IVIVC, PK, NLME/PopPK,…) estimated runtime is about 40 hours. ‘Validation’ should be done everytime to OS is altered (not only service packs). This would include Hotfixes/Patches which are distributed by M$ monthly. Your productivity would go down by 25%. In a larger company hotfixes are centrally distributed, which means that you can’t even retreat to another machine in the meantime. Anyway I would call everything you obtain from a SW vendor (how extensive it every might be) not validation but qualification. It’s up to us to find out the flaws.

I once attended a course on WNL modeling near Paris where 20 computers were available to the attendees. WNL was installed but malfunctioned on each and every one of them. The course director was rather perplexed. It turned out to be a conflict between some hardware driver and WNL that was the problem. Which meant that the conflicting hardware had to be deactivated on all units (was not essential, iirc it was a token ring i/o driver. Yup back in those days!). So to rule out unpleasant regulatory interrogations I guess all validations should be done in presence and in absence of any other piece of software or running exe/driver on the target machine, plus all their possible interactions.

"But you didn't validate when Minesweeper, MS Excel and Adobe Suite was running and while your printer driver and RSS reader was turned off. I'll give you a 483, sir."

❝ Cough. (at least one)

Still active?