FORUM CTRLX AUTOMATION
ctrlX World Partner Apps for ctrlX AUTOMATION
02-21-2023 10:09 AM
Hi,
is there a ctrlX HMI Software which is compliant with the 21 CFR Part 11 regulation.
Means there is an audit trail, user managemement, recipe storage, electronic signature and additionally a good template for standardization.
Does anyone have a recommendation.
Is such a function planned for the ctrlX.
And is it even possible to run an electronic recording HMI software on the ctrlX, due to safety and storage reasons?
Thanks.
Solved! Go to Solution.
02-23-2023 08:35 AM - edited 02-24-2023 01:45 PM
Our actual main HMI supplier "Smart HMI" with their "WebIQ Designer/Server" does not support such features at the moment. But we are checking the alternatives "Weidmüller GTI - PROCON-WEB Embedded System" and "CODESYS - WebVisu".
02-24-2023 12:33 PM
Dear user,
Smart HMI is working on a solution for an FDA compliant solution of an audit trail according to CFR21Part11 and will be available at the end of 2023. Whether it could be used on ctrlX code has to be discussed, e.g. Integration of remote databases.
If you write me on the private channel we can discuss your requirements in detail.
Kind regards
webiq-eg
03-03-2023 04:11 PM - edited 03-03-2023 05:52 PM
Today, PROCON-WEB ES (Embedded System) for ctrlX does not comply with FDA 21 CFR Part 11 requirements. PROCON-WEB SCADA (PC based) covers quite a range of the requested functionalities, but does not have FDA approval today. If this is an option to use, we will be happy to discuss.
Contact: Sohrmann, Dr. Rolf <Rolf.Sohrmann@weidmueller.com>
By the way: The architecture and ctrlX CORE's access concept natively supports the mentioned security requirements.
11-13-2023 02:59 PM
@webiq-eg Any news here?
06-14-2024 04:52 PM
@webiq-eg any news about this topic?
08-05-2024 01:20 PM
The new WebIQ version 2.16 (planned for September 2024) will support the mentioned FDA norm (21 CFR Part 11)
08-05-2024 02:47 PM
Hi,
as PMar already said, the feature is coming with 2.16, we are on the last meters with the release and it will most likely come in September 24.
It contains:
- Audit logger with encrypted database
- Export of signed audit log data with public key encryption, according to the customer's wishes, e.g. by batch, by time period, etc.
- Verification of the exported audit log with WebIQ or a standard tool, e.g. openSSL. This can be used to check whether the log has been manipulated
- Audit log viewer widget for convenient searching and narrowing down log events
More to follow shortly.
BR
webiq-eg