We are often asked if OpenSpecimen is CRF Part 11. We say “yes” because based on an initial review we had done. It seemed to have met all the needs.
But we are not expert. Does anyone know better? Do you have any local experts who can help us with understanding what exactly needs to be done to safely and soundly say that “OpenSpecimen is CFR Part 11 complaint”.
Does it even matter?
Thanks,
~Sri
It’s not a good idea to say yes to something like this as validation (21 CFR Part 11 compliance) is a major undertaking and would mislead potential adopters. I wrote up the steps needed to validate a computerized system here https://wiki.nci.nih.gov/display/TBPTKC/Computer+System+Validation. I believe these steps are still valid although I’ll add the disclaimer that it’s been 10+ years since I have worked in the pharma/FDA regulated field.