Are These Non-starters For Manufacturing Use?

Functional Questions and Answers
1

Hello Community!

It was great to discover this mature and capable open source LIMS system and the active community around it.

Our Use Case
We are manufacturer of blood testing products for hemostasis labs. At the start of our supply-chain we receive donor plasma samples for evaluation of suitability for manufacturing our products. After purchase, this Plasma is pooled to produce Fractions (blood with a specific factor removed) for sale or as inputs into other products. We are looking for a solution to track these Plasma samples, Fractions, specifically in-house testing results and specifications, and the relationship between the two entities.

So Far
We have installed SENAITE to gauge its suitability for our use. We understand that SENAITE is primarily used for labs, not manufacturers, although there is some overlap in our business. After working through the ‘Getting Started’ and subsequent documentation in the system, we still have some significant outstanding questions that will determine if SENAITE can be adequately configured for our use.

Samples arrive from Suppliers as a supplier-specific spreadsheet and include anonymized donor information. Samples that are purchased are used to create Fractions (plasma with a specific blood factor depleted/removed). Both Samples and Fractions have in-house testing-to-specifications performed by analyzers.

Key Functionality In Question

  • Can custom fields be added to the Sample and Fraction entities?
  • Can supplier-specific spreadsheets sheets be setup for bulk import of Samples?
  • Can a traceable relationship between Plasma Samples and Fractions be represented?

It is difficult to comment on a limited scenario but with your experience with the SENAITE system, please do not hesitate. If I missed existing posts that already answer my questions, please forgive me and just point me at them. Thank you in advance!

Regards from Nova Scotia!
Rob T

2

I’m not an expert, but I’ve been in the same situation as you. For a pharmaceutical manufacturing industry.
I can help with your questions:

  1. Can custom fields be added to the Sample and Fraction entities?
    Yes, you can add custom fields. The best recommendation is to create your own addon and link it as a subscriber to Senaite.
    This allows you to keep the Senaite codebase clean. I can provide you with a basic addon that allowed me to add a field to the sample fields.

  2. Can supplier-specific spreadsheets be setup for bulk import of Samples?
    I think doing it through the API is the simplest solution, although I think I’ve seen an addon that already does this.

  3. Can a traceable relationship between Plasma Samples and Fractions be represented?
    I believe the relationship is established when the aliquots (partitions) are created; a relationship can be established from there.

3

Hello,
Thank you for the detailed answers! Very helpful. Sorry for my tardy reply as I have been away. I would certainly appreciate a copy of your generic Add-on to continue our assessment.
Thanks again,
Rob T