Converting paper records to electronic then destroying originals

[Brendaisab]

Hello All,
We (Medical Device manufacturer) have tons of paper records. To reduce the amount of "old" physical paper records we would like to scan the originals and store the documents electronically. Once the originals are scanned/stored electronically, we would like to destroy the originals.
Is there a ISO standard on the requirements or maybe an FDA guidance on how to do this? I'm guessing we would have to apply a certification e-signature on the scanned record stating it's a true and accurate copy of the original.
FDA 820.40 Document Controls section doesn't address the conversion of paper to electronic records and the destruction of the paper version. Neither does ISO13485 Sec 4.2.4 & 4.2.5
Could anyone point me in the correct direction? Or is this not acceptable practice?

 

[Jen Kirley]

Welcome Brendaisab!

We are not legal authorities. Do you have a legal authority in your organization who can help you? This is a very important decision.

 

[Tidge]

21 CFR 11 is the relevant reference for the FDA's compliance expectations around electronic records. There is more involved with electronic records than just compliance of course.

 

[Jean_B]

Conquer your inner introvert and ask industry.devices@fda.gov / dice@fda.hhs.gov for their (USA based) expectations. If they give an answer that makes sense and is transferable, please post back.

[Note: I did so for the 21 CFR Part 11 trail that would lead to a "Letter of Non-Repudiation" and got an only slightly helpful answer back from dice@fda.hhs.gov which if I interpret it strictly as written probably means major non-compliance across industry]

 

[Ed Panek]

Conquer your inner introvert and ask industry.devices@fda.gov / dice@fda.hhs.gov for their (USA based) expectations. If they give an answer that makes sense and is transferable, please post back.

[Note: I did so for the 21 CFR Part 11 trail that would lead to a "Letter of Non-Repudiation" and got an only slightly helpful answer back from dice@fda.hhs.gov which if I interpret it strictly as written probably means major non-compliance across industry]

I have great results from asking questions to DICE. If you are uncomfortable putting the question out there they also respond to @gmail accounts

 

[Ron Rompen]

Just interjecting a note of caution here. Electronic records, although very useful, do have some flaws of their own. They are subject to data degradation (ask your IT department about it), obsolesence (your data file that you saved 10 years ago may not be compatible with the software you are using today), accidental erasure, and hacking.

 

[Bev D]

Nothing is perfect as you say. Of course paper records can get lost, mutilated, wet, and burned.
My father lost or misplaced his DD-214 and the ‘original’ was lost in a fire in an army archive in Kansas. Fortunately since he needed it for the GI Bill college thing his college had a record (from the fifties!!!). It was stored on microfilm.

If something is extremely important there should be multiple copies in various media and disparate locations…I doubt that the OP has more than a few of these in their QMS records - unless they are in the aerospace & defense industries…

 

[ScottK]

I wouldn't recommend destroying the paper records. Yes - I would scan them and make them searchable, but I would store the original paper records for the required amount of time in your procedures before destroying them. There are companies out there (like Iron Mountain) who will store your paper records at their site and give you a guaranteed retrieval time if you need some.