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Do hard copies of quality records have to be retained?


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For example, we scan all of our DHR's into our backed up network. Our Doc. Control employee reviews the scanned DHR's to ensure legibility and that all pages were scanned. We toss the hard copies after that.

Our sister company recently informed us that they retain all hard copies and when their internal storage gets full, they outsource the storage to an outside facility. The QA director's reasoning was that the FDA considers them to be source documents and require they be permanently retained (well, for 55 years).

I reread CFR 820 and ISO 13485's section on control of records, and did not read anything about source documents and hard copies being permanently retained.

Does anyone have any insight into this?
You will want to look over FDA 21 CFR Part 11.

Curious: where did you come by the "55 years"? By 21 CFR 820.180:
"(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer."

Is the expected life of your device 55 years?
Also, here is an older thread discussing this.

MIREGMGR's post on that thread concludes:

...a scan or other image of a document carrying an original physical signature is acceptable only if a separate process at the time of scanning or imaging has verified that the scan or image is a true copy, and that separate process has been attested with the signature of the responsible individual.
Note that this only relates to US FDA policy on documents with signatures, and the thread is old (2009), so I don't know if the FDA have since modified/clarified this position...
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