V5 is validatable, not validated for your use. Enterprise includes IQ/OQ and validation support — URS, FS, configuration spec, IQ/OQ protocols, traceability matrix and periodic-review templates, scoped in your quote. Your team runs intended-use testing and PQ and approves the validation report.
Both. V5 Ultimate runs as a hosted service operated by us (Cloud, or Private Cloud with an isolated application and database), or as V5 Ultimate On-Premises — a containerised, air-gap capable deployment in your own environment, where you own the database and encryption keys. The application code is the same; hosting responsibility and key custody differ. Hosting details are in the Security & Trust reference.
Yes, as the host. The V5 application tier runs as Linux containers, so on Windows Server it runs inside a Linux VM (Ubuntu 22.04 or RHEL 9) under Hyper-V. Sites that standardise on VMware, Nutanix or Proxmox instead run the same Linux VM on those hypervisors. For regulated (GxP) sites this Linux-VM pattern is the one the shipped IQ/OQ pack covers. Docker Desktop is not an option on Windows Server: Docker does not support Docker Desktop on Windows Server editions, including 2019 and 2022. Docker supports Docker Desktop (with WSL2) on client Windows 10 and 11 only.
Only relevant at regulated (GxP) sites. The Enterprise IQ/OQ package covers the Linux-VM pattern — a Linux guest on Windows Server Hyper-V, or on VMware, Nutanix or Proxmox hosts — at no extra cost. Docker Desktop is not an alternative on Windows Server — Docker does not support Docker Desktop on server editions of Windows — so validating any other stack for a regulated site would be scoped separately. Non-regulated plants don't need an IQ/OQ pack — pick whichever option fits IT.
No. The V5 application ships as Linux OCI container images — there is no Windows-native binary of the app tier. On Windows Server it runs inside a Linux guest VM on a Windows hypervisor such as Hyper-V. Docker Desktop is not an alternative there, because Docker does not support it on Windows Server editions; on client Windows 10/11, Docker Desktop uses WSL2 to run Linux containers. Postgres, by contrast, can run natively on Windows Server as the database tier.
Try V5 with your own records, or ask a question first. Ask V5 opens with an editable question; nothing is sent until you choose to.
