J
Dear Experts,
I work with a small firm located in the US. We want to completely outsource creation and maintenance of all quality systems documents to a consulting firm. Only an accountant and few R&D engineers are at the company site. Is there any minimum staff requirements per the 21 CFR Part 820 or FDA QSR that must be there at the company site?
Even though we are outsourcing everything to a consulting firm, do we need to have Quality Engineer or Director at the least at our company site?
Is there anything specific that you would recommend to look for when selecting a consulting form to maintain our QSR documents?
Thanks a lot!
Jen
I work with a small firm located in the US. We want to completely outsource creation and maintenance of all quality systems documents to a consulting firm. Only an accountant and few R&D engineers are at the company site. Is there any minimum staff requirements per the 21 CFR Part 820 or FDA QSR that must be there at the company site?
Even though we are outsourcing everything to a consulting firm, do we need to have Quality Engineer or Director at the least at our company site?
Is there anything specific that you would recommend to look for when selecting a consulting form to maintain our QSR documents?
Thanks a lot!
Jen