V5 is validatable, and Validated Enterprise customers receive a full validation pack: URS, FS, configuration spec, IQ/OQ/PQ protocols, traceability matrix, validation summary report, and periodic-review templates aligned to GAMP 5.
Both. V5 runs on Lovable Cloud for fast time-to-value, or as V5 Ultimate On-Premises — a containerised, air-gap capable deployment where the customer owns the database and encryption keys. The application code is identical; only the hosting and key custody differ.
Yes. For regulated (GxP) sites the pre-validated path is a Linux VM (Ubuntu 22.04 or RHEL 9) on the customer's Hyper-V, VMware, Nutanix or Proxmox host — covered by the shipped IQ/OQ pack at no extra cost. For non-regulated sites you can also run V5 directly on Windows Server via Docker Desktop + WSL2 under the standard support term.
Only relevant at regulated (GxP) sites. The shipped IQ/OQ pack covers the Linux-VM-on-Hyper-V (or VMware / Nutanix / Proxmox) pattern at no extra cost. Validating a Windows-native install (Docker Desktop + WSL2 directly on Windows Server) for a regulated site is a chargeable engagement. 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 either inside a Linux guest VM (recommended, fully validated) or via Docker Desktop with WSL2 (Linux kernel under the hood). Postgres, by contrast, runs natively on Windows Server and is fully supported as the database tier.
