I've got clients using different systems. I'll say what I can but you'll have to check on prices and whether they will meet your needs. Note that ANY tool will likely need adaptations out of the box. So don't just consider annual license / service cost. Expect some time an energy internally to manage / maintain the system. I've seen a number of failed attempts because companies didn't provide sufficient support to get the tool properly tailored and maintained.
One is using QT9. I've not dug deeply enough but I'm not fully convinced yet of Part 11 compliance (for e-signatures). As I recall, there were some concerns. Otherwise, what I've seen is very positive. As Tempus noted, the support staff does seem quite helpful and the tool is fairly intuitive. As I recall, it is sufficiently adaptable and the adaptations were pretty straight forward.
One is using Verse. It required a good deal of tailoring to make it work properly. And adapting it requires a good amount of time and learning. But once you get the basics down, it's pretty straight-forward. Support was always pretty prompt and helpful. It certainly can be compliant with Part 11. They provided a validation package but I felt it was generally useless. They tried to cover everything the tool does in every way possible. It would have taken 2 months just to execute what they provided. You're better off doing your own validation.
A third is using QCBD. I've only been involved on the periphery so I can't really say much. From what I did see, it didn't seem like there was a lot of tailoring / adaptation. I don't know if QCBD helped out or if it's just ready-to-go.
Most of these companies offer a free trial. Before you take them up, though, have a good idea on what you want your processes to be (and what processes you want to put under the tool). Make them show you, for example, how to tailor it to meet your document flows, including signatures and changes.
