FDA 21 CFR 820 QSR Quality Manual example wanted

S

santhosh741

#1
I am developing a quality manual for a small device company and which is strictly aligned to 21 CFR 820 QSR. I would appreciate any sample quality manuals, SOPs and other procedures based on the same.

Thanks
 
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Ajit Basrur

Staff member
Admin
#4
I am developing a quality manual for a small device company and which is strictly aligned to 21 CFR 820 QSR. I would appreciate any sample quality manuals, SOPs and other procedures based on the same.

Thanks
Just to check with you - do you have an ISO 13485 manual ? If yes, you could have the same with a table referencing the 21 CFR Part 820 elements in a tabular form.

Refer this Quality Manual as an example.
 

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