H
hlg1102
I currently oversee training records for a small medical device company. Our field sales personnel are intending to use a cell phone app. known as SignNow to sign training forms which are then faxed or scanned back to me. It allows the trainee to sign on the phone screen displaying the training document.
I find this practice risky from an FDA compliance standpoint. Does it meet 21 CFR part 11? If not, can it be made compliant? I suspect there would be a validation requirement to use such software.
I find this practice risky from an FDA compliance standpoint. Does it meet 21 CFR part 11? If not, can it be made compliant? I suspect there would be a validation requirement to use such software.