What about the validation effort? Can you provide any insights on the validation process?
All the modules in Scilife are validated from our end, but we want to come up with a next version of the quality process design tool, that is, to have some pre-validated workflows. Therefore, the most standardized workflows will be available in a validated state.
Over time we will probably add workflows that are validated on our end, those will be the standard workflows that you can then build on. Obviously there will be a validation effort from your end but, should it be the case that you get completely blocked with the validation, definitely reach out to us and we'll assist you with additional validation services from our QA team.
The standard flows are not always meeting my requirements. In Quality Process Designer, can you clone a standard workflow and make smaller modifications?
Totally, you can. That's the really cool thing about the quality process designer tool. You can create workflows from scratch or you can use standardized workflows, clone them and perform the changes that you'd like to make as you go.
I would design processes like CAPA’s, events,and change control in the Quality Process Designer tool. Do I need to keep the access to the standard modules?
I would say it depends on you. We have customers that really want to keep the standardized modules. For example, let's say that you're working really well with CAPAs and with change control tools, and you have one workflow in events that's working all right with you, but you have a series of other events where you really need a customized workflow. In this case, we have customers that want to have the out-of-the-box standard workflows within the standard modules, and then they choose to create these specific workflows within the quality process design tool.
We also have other other customers who really want to have everything in one place, just under the quality process design tool. They set up what would be the same as the standard workflows within the quality process design tool. In that way, people only have to go to one place to set up the workflows.
The tool really gives you the flexibility to decide whether you want to keep the standard modules as well as the Quality Process Design tool, or just the latter.
Would Scilife be able to do the creation of new workflows for us? This module is very nice but we do not have resources to do this kind of work.
Yes, Scilife does offer this service, absolutely.
