Minimum staff per 21 CFR Part 820

J

Jennifer27

#1
#1
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
 
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T

treesei

#2
#2
I don't think 820 specifies the minimal staff number or the necessary function on site.

TO select a consulting firm, I would look at my needs in doc control etc., compare them to the requirements, and come up with a "I want" list. Ask the candidate how they will satisfy your needs.
 
P

phoenix2368

Starting to get Involved
#3
#3
It depends on what kind of manufacturing your company has and what class of medical devices you guys carry. I think there supposed to be someone to play a role in QA within the company familiar to your day to day operations and has knowledge of devices you carry.
Consulting firm can deal Complaints, Complaint Investigations, Can suggest Corrective and Preventive actions, can make decisions on recalls (if needed), Issuing of NCMRs etc but they would be asking a lot of information all the times and i think it would not be the consulting firm who would be receiving the devices and doing inspection and testing activities. There is always a chance that some product would be non conformed, so your company would be able to relay everyday record to the consultants or they themselves would be doing all inspection and testing activities and than releasing the stuff to your company for onward release to the customers.
Everything depends on the size and operations of your company.
If your company is a small entrepreneur and is working more like an initial distributor than probably it would work out fine.
 
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