Reply To: Do we need to Keep a hard copy in the Paper Document in file Room

Home › Forums › General Discussion Forum › Do we need to Keep a hard copy in the Paper Document in file Room › Reply To: Do we need to Keep a hard copy in the Paper Document in file Room

August 16, 2021 at 6:05 pm #4233
Christy Nini
Participant

I think it would depend on what your SOPs define for you. If they are not yet defined, then I think that once you have a Part 11 compliant eTMF system, then you don’t need to duplicate your work by retaining hard paper copies UNLESS there are certain exemptions surrounding cases like wet-ink signatures.