As part of our Medical Device Risk Management process, we've elected to do onsite audits annually of contract manufacturers and suppliers where we own tooling. I currently have two which need to be completed, and certainly more will arise as the pandemic continues.
I'd prefer not to re-write the procedures, but would like to build in some flexibility for the current situation. I was leaning toward conducting virtual audits and approving via deviation process.
Has anyone's NB provided helpful guidance to this end?
I'd prefer not to re-write the procedures, but would like to build in some flexibility for the current situation. I was leaning toward conducting virtual audits and approving via deviation process.
Has anyone's NB provided helpful guidance to this end?