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Question about data storage

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Guest user Created:   Jul 05, 2021 Last commented:   Jul 08, 2021

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

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 08, 2021

Raw data do not need to be in eLN, it is enough to refer to the documents containing data.

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