Hello All,
I saw couple old posts (back in 2005) that mentioned a little about compliance with 21 CFR Part 11. I am curious if there is any new Allen Bradley products that can easily compliance with this FDA regulation (21 CFR Part 11).
I am currently working on a project with a pharmaceutical company. We will be building an electrical control panel and the customer requested the control panel to be compliance with 21 CFR Part 11. I am still new to this FDA regulation. I was thinking to use Allen Bradley ControlLogix as PLC and Versaview as the local HMI mounted at the front panel door. Then I will install either RsView32 or RsView SE on the Versaview for all the data logging historians and audit trail for electronic signature. Would this configuration be sufficient to meet the requirements of 21 CFR Part 11?
I hope someone who familiar with this can provide me some guidance on these questions. Appreciate it. Thanks
I saw couple old posts (back in 2005) that mentioned a little about compliance with 21 CFR Part 11. I am curious if there is any new Allen Bradley products that can easily compliance with this FDA regulation (21 CFR Part 11).
I am currently working on a project with a pharmaceutical company. We will be building an electrical control panel and the customer requested the control panel to be compliance with 21 CFR Part 11. I am still new to this FDA regulation. I was thinking to use Allen Bradley ControlLogix as PLC and Versaview as the local HMI mounted at the front panel door. Then I will install either RsView32 or RsView SE on the Versaview for all the data logging historians and audit trail for electronic signature. Would this configuration be sufficient to meet the requirements of 21 CFR Part 11?
I hope someone who familiar with this can provide me some guidance on these questions. Appreciate it. Thanks