One of our customers is requesting some info before approval of the design for their unit.
They add the note below:
“PLC/HMI System must comply with FDA 21 CFR part 11”
Can you please find out if Weintek HMIs comply with FDA 21 CFR part 11? If so, can you please provide a document stating the compliance? Model is CMT2078X
To my knowledge, an HMI/PLC vendor cannot state that its product complies with FDA Part 11. The software shall provide the necessary tools to allow a user to create a system (application) that is compliant with FDA Part 11.
Please go to the “Technical Notes” section on the forum and find “FDA 21 CFR part 11”, which includes guidelines on how our HMI could provide methods to comply with FDA Part 11.
A SCADA solution could be friendly for FDA Part 11 compliance.
I am quoting from an article:
The purpose of part 11 is to establish the criteria under which are considered trustworthy and reliable and to ensure that they are properly managed and controlled.
Part 11 also sets forth the requirements for businesses that wish to use electronic records and electronic signatures (ERES) in their operations.
To comply with Part 11, businesses must put in place policies and procedures for managing ERES to ensure the accuracy and security of their electronic records and signatures