Enforce reason for value change
Link to original flash recording
| Time | Topic |
|---|---|
| 0:00:25 | Presentation |
| 0:21:18 | Demo |
| 0:51:00 | Q&A |
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Hi Hubertus,
the value that was originally entered is (currently) not part of the data that we add to the data XML when the reason for value change is recorded. We did not include this information to keep the display of the reason data simple and clearly laid out.
To record entered values the event log creation functionality has to be activated for the appropriate control recipe/instruction destination. But this may have an impact on the overall performance of the PI Sheet maintenance.
I’m not sure if displaying the old and new value as part of each reason for value change data record might reduce the ease of consuming this kind of information. Alternatively the original value could be recorded and displayed when the first reason for value change is recorded. Further changes of the field values will result in new recodrings of the reasons for value change. The previous value then can be derived from the history of value changes. This would keep the data XML small (think of changes on long text input values…).
What do you think?
Hi Uwe,
thanks for your reply to my message.
Our written procedures requires, and I think, that derives from FDA regulations, that the original value is still readable after value change. In a paperdocument I have to cross out the wrong value and note down the new value, incl. reason and signature. But the old value have to be readable.
For electronically entries we have the same requirement, the old/wrong value have to be readable/visible.
That’s the reason for my question.
In your last paragraph you suggested to record the first entered value together with new value, the reason for value change and signature, when value was changed the first time. For the second change the changed value can be taken from previous change. In this case all data are available and comprehensibly. But will this be sufficient for an FDA auditor?
Regards, Hubertus
Hi Uwe,
I watched your demo today and found it very interesting, because we are looking for such a functionality for our PI-sheets
In the section where you have showed the audit trail, I have not seen the original entered value that was changed. There is only the new value visible, incl. reason and signatures. Is the original value still available? Where is it available?