CFR21 Part 11 / GAMP5 normatives

ERPNext
1

Hi,

Do you know if ERPNext does comply with any of these normatives?

Sometimes its requiered to have these kind of software validation to be able to implement ERP software on a company, searching the forum I could not found any of these two terms.

For i.e. SAP ERP (that lucrative elite ERP) has these validations and adds value to the final product or maybe its one of the main causes a company chooses it.

Here some links about it:

CFR 21 Part 11

GAMP5

Hope you can enlighten me,

Thanks,

2

Hi @sebadamus,

thanks for sharing this.

Out of the box, ERPNext certainly has some shortcomings with respect to CFR21 part 11 (e.g. a signature before submitting a document, prevent deletion, …). However, with some additional effort it should be possible to get the system to that level (I have seen it being used in an ISO 13485 context). I guess especially for the healthcare segment, many of these standards would apply as well. Yet, I understand that for the most ERPNext users, it would be too restricting. Maybe a guide on how to configure ERPNext for part 11 compliance might be handy, but requires quite some effort :wink:

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3

Thanks for you response @lasalesi!

First have to implement little more with ERPNext (just start learning now), but would be a good idea to start a “validation” then so this wonderful ERP will get stronger in healthcare, laboratories and so on…

4

I’m using It in a Lab… First efforts now, and qualifying for a GMP… If some of you can gimme some highlights, it would be awesome!!!

5

Hi!

If you are qualifying for GMP, you can first try to search for some guides online about GAMP5 and CFR21 part 11. These guides (specifically GAMP5) has kind of step by step to make the “qualifying tons of papers”.

Try to search for this first… then if you are in a company, surely you have Quality Assurance department… this kind of work have to be guided also wit QA team.

6

Thanks!! I will… In Brazil, I will have to hire a certification company… huge job!!

@lasalesi, I’m exactly trying to use it at ISO 13485 context… Any tips?

7

Hi,
could you provide me where it has been used in an ISO13485 context? I’d like to know how much effort was required to make ERPnext ISO13485 compliant starting from the standard version.
Thank you

8

Hi @cristianwise,

the examples I know are partly based on App extensions and mostly on configuration, so it is difficult to point you in the direction of something like a how-to… It was a huge effort from the Q team, all processes had to be built up.

If CAPA is a key topic, have a look into ERPNextSwiss, it covers the CAPA/8D process.

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