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Using Laboratory Notebooks in R&D and Design and Development

duff999

Involved In Discussions
#1
Question regarding the use of laboratory notebooks in design and development - does anyone have information on using Lab notebooks in design and development and will the use of the lab notebook support the verification process or do I need to create a separate verification plan, protocol and test summary report?

Any feedback is appreciated.
 
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Tidge

Trusted Information Resource
#2
My preference would be that you have an approved verification plan which allows (among other methodologies) the acceptance of lab notebook contents as evidence of verification provided that the contents are subject to an independent (and critical) review. If the lab notebooks are subject to appropriate controls and the documentation within them is not suspect in anyway (records are cleanly made by an identified person on a specified date, records aren't 'back-corrected', etc.) then it is possible they might serve as evidence of verification.

The lab notebooks would become part of the Design History File and would be subject to all the necessary documentation controls for such records.

Generally, I would prefer that protocols be created and approved prior to verification testing. Verification testing is also intended to be done on established/released/controlled designs with validated test methods, specified (and if necessary calibrated) equipment, and trained testers.

I've kept lab notebooks myself (for a variety of medical device compliance-adjacent reasons) and I would prefer that people not poke around in my notebooks as objective evidence. I've written up analyses based on my notebooks for consumption by folks looking for something specific, and let those write-ups be my official account. To my knowledge such reports have never been used as design verification.
 

duff999

Involved In Discussions
#3
Thank you for your response, you've made some very good points that I did not think about. The lab notebooks are subject to document control but currently we don't approve the protocols prior to running the experiments, these are documented, and can not be back dated, but as far as getting the verification plan and protocols approved this is not happening as it would under similar design controls. Perhaps I could use the findings from the lab notebooks to feed into the verification plan/protocols
 

yodon

Staff member
Super Moderator
#4
Completely agree with @Tidge but if you do want to use lab notebooks, you have to really kick it up a few notches to ensure data integrity. I wouldn't do it for design V&V.

Perhaps I could use the findings from the lab notebooks to feed into the verification plan/protocols
Without the pre-approved protocols with the pre-determined acceptance criteria, you run the risk of giving the impression that you tested into compliance. You'd probably need to take extraordinary measures to avoid that impression. Again, I wouldn't do it.

We've used lab notebooks before but only when we wanted to capture early design notes in the event we needed to support patent application claims (and had to jump through the data integrity hoops when doing so).
 
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