FDA - CAPA (Corrective Action and Preventive Action) & Complaint Database

C

Cinti

#1
#1
Hi,

We are planning to have database for CAPA and customer complaints. Is there any mandatory format recommended by USFDA for these databases? Is it mandatory requirement to maintain database? Kindly give your inputs.

Cinti
 
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sagai

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#2
#2
Welcome ! :bigwave:

Your system from the functional prospective shall comply with 21CFR820.100 for CAPA and with 21CFR820.198 for complain records.

Moreover in case you are not planning to use handwritten signatures on paper based record, than also the system shall comply with 21CFR11 and with its guidance . :bonk:

And only for reference purpose, when "documented" referred in the CFR, you shall comply with 21CFR820.40 .

If the above enlisted requirements are absolutely new for you, I would not advise to do it alone in your company. :nope:

One more think...

When your system is ready, before its used you shall comply with 21CFR820.70(i) and as such you shall validate this system, advisable based on GAMP4 or 5.
I think in brief, that's it that's all.


Regards
Sz.
 
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