Electronic Signature Documents - FDA Requirements for Retention and Hardcopy

D

ddstarship

#1
what is FDA retention requirements for hardcopy document that are maintained as electronic signature documents? Thank you
 
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sagai

Quite Involved in Discussions
#2
Are you maintaining hardcopy and the content of the hardcopy in electronic records with electronic signatures parallel?
Regards
Sz.
 
D

ddstarship

#3
the original doucment was signed, I scanned it to create a pdf of the doucment so that I could issue a document control number and release it into our document control system. I did not need to use our electronic records, signature system for this document since I had the orginator's handwritten signature on the document. it seems like I read somewhere that FDA requires that even in a electronic document controlled evnironment we are required to keep any notes, records containing handwriting or documents containing handwritten signature. I might be getting this confused with the requirements for clinical labs.
 

sagai

Quite Involved in Discussions
#4
My impression is in case you can uniquely identify the hardcopy and longterm archive that till the end of the medical device lifetime, than basically you have nothing to do with the scanned one.
If you want 1oo% sure, for each scanned paper write a statement saying "can not be used as a valid copy of the original hardcopy" or something similar, excluding its formal usage.

The problem is coming from part11 guidance, saying:
"
if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record.
"
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm
Nevertheless this is a case you shall avoid, otherwise you shall validate the document scan system.

regards
Sz.
 
D

ddstarship

#5
thank you so much for your time and wisdom. With your help interpreting the regs I believe I can now find my way.
 
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