as i read the various FDA guidlines the only two rules that need to be adhered to in order to avoid a technical rejection are 1734 and 1736. Is this still the case or have other rules been added?
To elaborate a bit further. Especially i TS the start date parameter must be in place. Let's for argue sake say that ACTUB was filled out incorrect. That would not lead to a technical rejection since it won't be checked by a machine.
Is my understanding correct that technical rejections only can occur when a machine finds and error and that only the two above mentioned rules are checked?
Forums: Validation Rule Suggestions
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