HMI software including audit trail, electronic storage and recipe management

[NiceGuy]

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.

[CodeShepherd]

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".

[webiq-eg]

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

[Pmar]

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.

[CodeShepherd]

@webiq-eg Any news here?

[Toffa]

@webiq-eg any news about this topic?

[Pmar]

The new WebIQ version 2.16 (planned for September 2024) will support the mentioned FDA norm (21 CFR Part 11)

[webiq-eg · Accepted solution]

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