Alright, so going back to the FDA website.
There's some information here, you know, that you
can pull up around electronic data and Part 11.
drilling down on that in other documents.
And there, there's a lot of information out there.
I've pulled up one here and again referenced it down the left.
I've pulled this one up really because it had a pretty,
pretty decent definition of when you need it, and when you don't.
But I'll note to the top of this the
language that's at the top, there's some ambiguity on, you know, even on the part
of the FDA on how strict the requirements are and how much verification is needed.
But looking into that document around how they defined the scope of part 11.
they say here, in this documentation, that some have
understood the scope of Part 11 to be very broad.
We, however, believe that some of those broad
interventions could, could lead to unnecessary controls and costs.
And could discourage innovation.
as a result, they clarify that you know, they actually
mean, the interpretation of Part 11 can be quite narrow.
Under the narrow interpretation of the scope of Part 11,
with respect to records required to be maintained, under predicate rules
are submitted to FDA.
When persons choose to use records in electronic format,
in place of paper format, Part 11 would apply.
So backing up, like the thisma work, there's a lot of
documentation, there's a lot of validation of systems if you're going
to be using an electronic system in clinical trials work, in
work that, will eventually be submitted to the FDA, to the regulatory
groups, upstream.
And so it's important that you understand how to make that work.
It's also important, ahead of time, to know that
there is significant cost, there is significant effort there.
That they define it here as, as being invokable.
When the person, or the investigators choose to use
records, in electronic format, in place, of paper format.
So, they also go on to say that on the other hand.