Dear All :),
Good day, first time for me and hope post at the correct place.
I’m struggling with some 21 CFR part 11 interpretations and I’m new to this.
Some one could please give me some thoughts regarding the following it will be very much appreciated.
Currently, I’m tasked to setup a new manufacturing line for medical device. When at compliance to part 11, we are not sure the equipment process parameters need to be compliant with?
For Example; sealing machine which need to set the sealing temperature & dwell time. These parameters will be set at the HMI and will be verified period running. All these parameters need not sent to any regulatory body. Should these process parameters need to be compliant with part 11?
In term of Equipment Qualification, there process parameters was verified, tested and confirmed.
What are your thoughts?
Thanks in advance.