Microbiology pharmaceutical LAB


#1

Hello all very glad to be in this community.

I’m working in pharmaceutical Microbiology LAB where we follow the GMP documentation system we have (logbook notebook system).
Logbook: associate with device we have to record each activity we have done in the device with date and time.
Notebook: where we have to write our test details and the result.
usual micro LAB devices have nothing to do with software because it’s too simple like incubators and colony counter and that required a lot of documentation to prove your data.

The question is can I reflect my documentation system on SENAITE ?


#2

Dear ahmadti,
I too work in the pharmaceutical business.
My impression is that at the moment you could use Senaite LIMS to document your work, eg. colony counting.
However, Senaite LIMS currently does not support electronic signatures according to US FDA’s 21 CFR Part 11 or EU’s GMP Guide Annex 11. That means, it is possible to use a LIMS like this, but you still will have a printed or other paper based report where you sign the work done.
This however, could be just printing a Senaite LIMS report and signing it --> but beware, GMP records need to be documented and signed in a timely manner, which means while or immediately after work was done.

I’m interested to have your input as well - let’s have a discussion.

Best Regards,
Andreas