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.
Part 11 is for electronic records and electronic signatures. The scope of electronic records is limited to records required by regulation (“predicate rule”). Parameters (stored) in and of themselves do not constitute electronic records. The first step in determining whether Part 11 applies is to identify the predicate rule that requires the record.
Though the parameters need not send to any regulatory body, but they are parts of electronic record, aren’t they? Any modification or changes to sealing machine parameters shall be controlled and trails are available whenever required.
Which record? That’s the key! The record has to be something that’s already required by a (predicate) rule. Which (otherwise paper) record would contain this data that you are required to keep?