[quote=sagar]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…[/quote]
Really you will need to perform a Part 11 assessment on the PLC to figure out what level of testing need to be performed.
I am not clear what you mean by “without windows HMI” can you expand on that please.