Hi Andreas,
as our lab is not regulated but accredited by german DAkkS we have to follow this guide:
https://www.dakks.de/content/leitfaden-zum-einsatz-von-computersystemen-akkreditierten-laboratorien
We plan to test, introduce senaite LIMS while auditing it by those guidelines. (…and keep records about this process)
If some topics will not be sufficient in technical sense we have to complement our processes with organisational measures.
Stefan