Document Retention - Discard hard-copies after scanning?

#1
Hello,

I work for a company that manufactures class I medical devices. We're certified in ISO 13485 and also follow 21 CFR part 820. Our business has continued to grow over the years, which means there's been an exponential growth in records, mostly production records. We are still running an all-paper based QMS and we're fairly confident that we've properly defined the duration in which we must retain our documents based on risk and 21CFR820.180, but despite our rather large storage rooms, we're beginning to run out of space and are considering the possibility of scanning these records to a secure folder on our network that is backed up daily so we can shred hard-copies and free up some much needed space.

I'm wondering if anyone on this forum has considered doing so, or executed a similar plan? If so, what difficulties did you have to overcome?

My biggest fear is that an auditor will insist that each scan needs to have a documented verification that all pages are present and legible prior to shredding. Perhaps someone has successfully validated a scanning system that was acceptable during QMS audits?

Any input is appreciated!
 
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shimonv

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#2
Hi,
In essence, you want to make a transition into electronic records. You should review 21 CFR Part 11 on Electronic Records; Electronic Signatures.
I am not aware of a commercial validated scanning system, but you could purchase one of the part 11 compliant software for handling QMS and implement just the 'Document Controls' module. It's a good way to start a transition to paperless system.
 

Richard Regalado

Trusted Information Resource
#3
You need to verify if there is a legislation on the use of electronic vs paper records. I believe there are countries who have antiquated laws in relation to document media and format.
 
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