Original Data Copying to Maintain Compliance with 21 CFR Part 820.180

G

greenfish

#1
To maintain compliance with 820.180:

I have original data, I then copy that onto another record for storage. I sign/date the new record indicating the data is correct, per procedure.

Potential for error still, yes. However, the person is taking responsiblity that the copied data is correct.

Would an inspector find issue with this? Im torn and leaning one way, but am not convinced. Anyone?
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
To maintain compliance with 820.180:

I have original data, I then copy that onto another record for storage. I sign/date the new record indicating the data is correct, per procedure.

Potential for error still, yes. However, the person is taking responsiblity that the copied data is correct.

Would an inspector find issue with this? Im torn and leaning one way, but am not convinced. Anyone?
Hi,

Any human recording is prone to error, even when originally capturing data.

If you have particular reasons for concern, perhaps consider either (a) automating the copying process (+validating the process); or (b) double checking the copying by another person, who will also sign and date (still, not 100% proof, however...).

My :2cents:

Ronen.
 
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