How to handle identification and validity of electronic controlled documents under ISO 13485?

In our practice, we usually watermark obsolete documents when archiving them. We also have a policy that users should always retrieve the latest version from the official repository. Basically, any PDF copy you send or download can become uncontrolled the moment it's out of the system, so it's important to make this clear in your procedures.

It's not unusual to have a mention in your document control procedure about the status of electronic copies, especially if you occasionally need to send out controlled copies. You could specify that only documents accessed directly from SharePoint are considered controlled, and recommend marking or watermarking any copies sent externally with the date and a note that they're valid only at the time of issue.

Some companies do use a 'controlled copy' label with a date, but it's more important that your process ensures people know where to find the latest version and that obsolete versions are clearly marked as such. The key is to describe your approach in your document control procedure and follow it consistently.