Ftv 10

Hi, Have anyone worked of FTV 10 For 21 CFR Compliance, i want to know is FTV 10 have function assisting 21 CFR & Which Hardware and Software require to use it.

Welcome to the forum, Omkar.
I know nothing about 21 CFR compliance but it may be helpful to others if you clarified which type of FactoryTalk View you are using (ME, SE Local, SE Network Distributed, etc.)

Thanks RonJohn for reply, i am currently using FTV 9, and want to upgrade to FTV 10 for 21 CFR compliance, before purchase i want to check is it possible to fulfill all requirement with FTV 10.( I want to generate Audit report and print it, and want to know which are essential software and hardware.)

I believe that any PanelView running ME v.10+ can automatically do audit logging and store to a .CSV file or whatnot. Looks easy to set up but I haven't tried it.

Is there anything else specific that you want to do?

There is a Rockwell White Paper on this subject.

It is not 100% compliant, but gets you close.

Google this....

Rockwell White Paper 21 CFR 11 Factory Talk View ME

You will get the white paper.

There is a tool to see if the CSV file has been adulterated.

SE is more geared to this I believe.

Thanks rupej & Celichi for the reply, I have gone through the Rockwell web site regarding 21 CFR, As mention there "Rockwell Asset management" Software is require to store and print the audit report. I want to conform that software is essential to generate and print CSV file or i can directly give an print command to printer to generate audit report. And additional software and hardware requirement for that.

There is a big difference between FTV ME and FTV SE. So first, clarify which platform you are using.
If ME, are you using Panelviews or running Station on a windows PC?

For ME -
AssetCentre is not required to view/print the audit logs. It simply makes it easier to manage the audit logs as you don't also have to deal w/ the limitation of removable media on a Panelview.
There is no buffering, If you lose the removable media, it fills up, or the system drops the connection to AssetCentre there is the possibility of data loss.
You will need to account for this and put in compensating controls or manage the risk.

SE is a whole different ball of wax.


https://literature.rockwellautomation.com/idc/groups/literature/documents/wp/ftalk-wp016_-en-p.pdf

Thanks Dravik for the reply.

I am going to use FTV ME with Panel View Plus

From your post it seems i can directly print audit and alarm report, i have gone through attached PDF.

have u used audit report print option for 21 CFR Compliance???

Thanks

We do not use ME for this due to the potential for data loss(no buffering, etc).

We do have SE systems that I use the audit reports from, after suitable validation of course.