Allocations FDA Compliance

Allocations FDA Compliance

Hi everyone,

IÂ've working on a project for a while and due to the client requirements I've been working on a very specific way.

I'm using the Recipe Group Manager to handle recipes. This recipes have to be very flexible and aditable at runtime. They also need to be able to be transferred from a PLC to another (up to 12 machines). Due to this requirements I handle most of the recipe data transfering from local variables, to each PLC variable, through ALLOCATIONS and different triggers according with the needs of the recipe. In order to keep track of the process I also use the historian tools and the report viewer to file/store the data and genereate reports.
On top of that I have to make sure my project is compliant with the FDA requirements.
My concern is:
- My recipe data transfering through allocations will cause problems to be FDA compliant? I also thought about transfer those data through the RGM but I read this:
"If the Read all values function is used with the Link with variable action for a
recipe, neither user authorization is checked nor is the action logged. If you
want a logging, you must create it manually, e.g. using a VBA macro.
Note for FDA regulations: As a consequence, this functionality is not
allowed to be used for projects with a strict FDA standard!

Mainly, the data I need to be 100% sure its FDA compliant, is the process data when the machine is working on a cycle, but I still don't know if I can separate which data has to be compliant or if the whole thing must be under the FDA rules.

I hope you can give some advice about this.

Thank you.


This is a migrated post! Originally posted on 10.05.2021 by user aherrero21. Please be aware that information can be outdated.

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