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?
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?