I am using Embedded HMI (firmware) at equipment level, the data entered in to the HMI with electronic signature, with user name and password will be considered as part of electronic record.the user name and password which we enter in HMI will be passed to PLC from there to SCADA to compair with windows security. can i validate and prove that my system is part 11 compliant as per GAMP 5
with out windows HMI cant we validate embedded HMI and meet part 11 requirement…