Question about data storage

I am following some courses on medical devices'ISOs on Advisera and I have been given this email to ask a particular question. I was wondering about the storage of data during lab experiments prior FDA/CE mark. We record everything on an electronic lab journal (protocol, procedures and conclusions) but I was wondering whether the raw date should also be embedded into the eLN or it is enough to refer to the documents containing data (sometimes big data) in order to be FDA/CE compliant. Thank you very much in advance