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
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…
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.
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.