Re: [bika-users] Part 11 Electronic Signatures

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lemoene

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Jul 22, 2014, 11:05:50 AM7/22/14
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Hi Perry

x posting to the Bika Health list

> Does Bika-LIMS currently have 21CFR Part 11 compliant electronic signatures and records?

Always wanted that but have not been exposed to it or had sponsors ask
for it. If will be most helpful if you could outline what Bika needs to
close the gap, it passes ISO 17025 and was enhanced for CLIA - ISO 15189
should be attainable too.

> Is there a current way to set up Bika-LIMS so that when data is entered(posted), Verified, and Published the user performing the action is prompted with an opportunity to re-enter their ID and password PRIOR to completing the action for verification of who the person is that is completing the action?

That is real easy to add, but wow is there not a more user friendly way?
Finger print readers? Short session time-outs? I am missing something?

Bests
l

Lemoene Smit

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Feb 25, 2020, 2:07:49 AM2/25/20
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Back for discussion at 21 CFR Part 11's Electronic Signatures.

The user list moved to https://users.bikalims.org/. The Health group stays put for now.

Bests, have good week
Lemoene
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