Data Collection - R&D / Lab Notebooks

P

prkatie

#1
I was recently asked by my R&D team if we could move our lab notebooks to some sort of binder system instead of the hard bound lab books.

The current practice to collect the data directly onto any excel sheet and drawing conclusions from the data, following that, the engineer would generate a purpose and report, print out the data and glue it into the notebook. The glueing onto the bound notebook seems to be non-value added activities.

The data is usually focused on feasibility, spec development, root cause investigations of failures or comparison between designs.

From my experience all data should be collected manually and recorded with a peer review to ensure validity of the data. In previous companies the rules were very strict.

However, given that the data is collected for feasibility and the results are analyzed before placing it in the notebook I am wondering if there are other ways of collecting data within other companies.

We are not ready to go to the Electronic Lab Notebook at this time
 
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normzone

Trusted Information Resource
#2
Why does the data get glued into the notebook? What doesn't work about maintaining it in a computer location with some link back to the notebook reference?
 
P

prkatie

#3
What doesn't work is that the computer programs are not validated for 21 CFR Part 11 compliance and can be manipulated after the data is all gathered.

Though, PDF or image versions may be another option, I will look into that.
Thanks for the idea.
 

Ninja

Looking for Reality
Trusted Information Resource
#6
As you look down this road, keep track of the original purpose of the Lab Notebook (as noted above...an unalterable record). And whether it still applies or not.

WHY did you need that record...do you still need it for the same reason?

I still mandate Hardbound notebooks for most activities in my plant.
Using XL only, or OneNote only starts the process of: warning--written warning--dismissal.

Why? XL and OneNote won't stand up in court to establish prior art in a patent fight. A double signed page in a Hardbound book can and has. (not every time, though, which is why the "will stand up" is not there)

Even if you look at a software package (Electronic Lab Book), consider shopping only among those that have had a test case or two through the courts.

If you don't need the books for that reason...consider what other reasons may still exist to still have them. Ask upper mgmt and legal (if any).
If there are no valid reasons to still have the hard-bound...XL and OneNote are both easier IMO.
 
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