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EudraLex GMP compliance

Hi!

Does anyone know if ERPNext complies with the Computarised Systems annex of the Good Manufacturing Practice? Can it be validated?

GMP, Annex 11

Thanks!

Hi Giuliano,

It have everything to be! I’m using it to run my in vitro diagnostic factory in Brazil, doing some similar to GMP. Here we call it CBPF (like a GMPCertificate).

You have to Validate your Usability, assuring that you are compliant with all the GMP topics, as security, redundance…

But, of all the systems I had tried, ERPNext is, by far, the better to do it. If you have a service provider to help you to validate all the tech stuff, and help you to customise all the (few) things you will have to change to adapt to your process.

What kind of company you are planning to run with?

2 Likes

Hi! Thanks for your response and sorry for the late reply. Greetings from your neighbour country, Argentina! Our company makes veterinary products, so we need to validate the QC of the lab. We have support from another company, that provides us ERP and I think can handle all the needed changes. Thank you very much. Your reply was very helpful.

Guay!

So, let’s exchange infos!

We are on the moment of increase our use, implementing manufacturing.