Photocopy of Data Entry in Traveler Forms

M

Mercurio

Hello all, I reviewed dhr and batch record documents in an internal audit (medical devices and pharmaceuticals). I found people prefilling common data (lot #s, dates) on documents and then making photocopies for the whole run/batch in the work order. As a common practice i found this unacceptable but is there a requirement other the company's QMS that says not to used photocopied data? Thanks
 

normzone

Trusted Information Resource
I've seen this before, but I don't play in the medical field.

I see no problem with common items (P/N, model #, job lot, etc.) being reproduced. I think that assembly and test identifiers such as signatures and dates should be live. Dates could be copied as long as they're accurate.
 
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