Hi,

Is there a plan to add GMP functionality to WinCC Unified? Most of our machines are built for the pharma industry and it's impossible to do it without Audit trail and other GMP requirements.

Is there any way to implement 21 CFR Part 11 of the FDA or EU GMP Guide Annex 11 requirements in WinCC Unified at the moment?

Hi,

there is no such functionality yet.

Regards

AutoGen_6288647

Hi,

Is there a plan to add GMP functionality to WinCC Unified? Most of our machines are built for the pharma industry and it's impossible to do it without Audit trail and other GMP requirements.

Is there any way to implement 21 CFR Part 11 of the FDA or EU GMP Guide Annex 11 requirements in WinCC Unified at the moment?

 This is a very important issue highlighted here. We are in the same position with machines and equipment for pharmaceutical industry based on Comfort Panel HMI and we are worried about the possible end of these Comfort Panels based on old Windows CE 6.0 O.S. (especially as we are seeing a lot of marketing effort from Siemens to promote the new Unified solution) and impossibility now to switch to Unified HMI as the GMP / Audit trail fonctionnality is not implemented yet (and of course we cannot program it by ourselves which will be a lot of money and technical risks..).

--> Would it be possible to have an official SIEMENS support feedback on this real issue (are the TP Comfort Panels going to be discontinued ? When can we count on the release of GMP option for Unified WinCC ?) Thanks in advance

Hi G.Wetzel,

please keep in mind that all users here are helping voluntarily/ in their free time and free of charge.

If you want an official statement for that you should create a support request, which you can find at the middle of the top from this page:

https://support.industry.siemens.com/tf/ww/en/header/supportrequest/

BR,

Noodles

I would be surprised if it would not be planned. The question is only then "when?" as I see.

I would assume, that as it is not just a quick fix topic, it won't come with an update, so next possible date is the next major version (V17).

When it will be announced with a feature list we shall see.

8Noodles

Hi G.Wetzel,

please keep in mind that all users here are helping voluntarily/ in their free time and free of charge.

If you want an official statement for that you should create a support request, which you can find at the middle of the top from this page:

https://support.industry.siemens.com/tf/ww/en/header/supportrequest/

BR,

Noodles

 OK. You're right,. Done. I have created a support request..

We'll see Siemens answer and I will update on the forum if I get one.

For everyone interesting in the GMP / Audit Trail functionality, here below the official statement from Siemens support team regarding availability on WinCC Unified : 

"Hello Mr Wetzel,

We thank you for your interest concerning Unified Comfort Panel and the WinCC Unified system.

Traceability is an often (and always more) requested functionality in our panels.

Of course this functionality is planned for our Unified Comfort Panels, just like for the WinCC Unified system on RT PC.

This functionality is first planned for our WinCC Unified system based on RT PC with the V17 (mid 2021).

The same functionality on UCP (Unified Comfort Panels) will come after and hopefully before V18.

If you wish to work with Unified and CFR21 Part 11 requirement, it will be first possible on PC and then on Panels.

If your project is for now, you have to keep our actual solution based on Comfort Panels / WinCC RT Adv or WinCC RT Pro.

Our Comfort panels range will continue to be actively sold until at least 2023, when all needed requirements like GMP are supplied with UCPs.

After the end of active selling of Comfort Panels, a at least 10 years long period will give you the after sales support on Comfort Panels.

I hope I could answer your questions,

With best regards,

[snip] "

WinCC Unified V17 Upd 1 seems to support GMP Audit trail on Comfort Panels

see

Information on updates for WinCC Unified V17 - ID: 109792171 - Industry Support Siemens