Is TV2 data secure, and how does it relate to 21 CFR Part 11?

Readings are written to non-volatile memory inside the monitor and cannot be edited there. Files downloaded to a PC are encrypted with 128-bit encryption and can carry an electronic signature, and TView shows an indicator confirming a file is still verified.

That combination is what sites rely on when they build a 21 CFR Part 11 oriented workflow around the instrument. Exporting to Excel deliberately breaks out of the encrypted format, so keep the encrypted file as the record and treat the spreadsheet as analysis.

Compliance is a property of your validated process rather than of any single instrument. Your quality team should confirm how the TV2 fits your procedures.