Can the ERP system on a multi-tenant host be validated under 21 CFR Part 820? What are the hurdles if code changes are divided into (a.) performance-related or (b.) functionality-related?
I think so, as per the FDA general principles of software validation, software must be validated under 21 CFR if it is used to achieve compliance with predicate rule. Could anyone tell me that what are the benefits of erp system on a multi-tenant? Thanks in advance.
open source erp
What is the problem? What are your questions? According a risk based approach following GAMP 5, I do not see any problem to validate a system on a multi-tenat host. I did not get the problem. May be you can explain a bit more detailed the problems you have?
Cheers gtf