FDA Rules and Requirements for Keeping Ink Signed Documents

[ryno fan]

Hello,

I work at an FDA-regulated software medical device manufacturer.

Due to the cost of storage space for paper documents, we want to move towards scanning all original ink-signed copies so we can store records electronically. Do we, by law or regulation, have to keep the actual ink-signed paper copy? Is it permissible to discard the ink-signed copy if we have a scan of it?

Thanks

[Ajit Basrur]

This is a great question

In fact, when I worked at Pharmaceuticals, we used to scan all the paper documents as backups and to mitigate the risk of loos / damage of hard copies.

[Marc]

Ajit - So you kept the paper copy and the scanned copy?

[Ajit Basrur]

In Reply to Parent Post by Marc

Ajit - So you kept the paper copy and the scanned copy?

Yes Marc

[MIREGMGR]

Ryno, are you familiar with 21 CFR 11?

Those rules have had an on-off-on-off enforcement history since they were first put forth. As far as I know, though, they still represent FDA's thinking as to the Gold Standard for document control and authorization/responsibility proof.

[Gert Sorensen]

If you validate your server in accordance with Part 11, and you validate your scanning process to ensure that you actually have trustworthy scans then the FDA accepts that you only retain the scanned document. This has been accepted since the days of the microfiche technology. Just remember that you have to have solid documentation that substantiates your claim that the system/process is validated for this use.

[jradford]

The servers I can understand. Retention and backup procedures. How do you qualify a scanner? Check legibility against the original signature? Does anyone have a process for this?