21 CFR Part 11 · EU GMP Annex 11 · GAMP 5 · ALCOA+
We follow the guidelines of SOC 2 Type II · ISO 27001 · EU AI Act
Pricing

Plans for every shape of validation program.

Volume scales by managed systems, not seats. Single Account, multiple Tenants — always included. No per-document fees, no signature charges.

SITE
€2,400 / mo

Single tenant, one validation team

Up to 25 managed systems
Up to 15 named users
  • AI ComposerUnlimited drafts grounded in your tenant
  • Validation lifecycleGAMP 5 phase-gated workflows
  • E-signatures21 CFR Part 11 — two-component, signed
  • Audit trailTamper-evident, exportable for inspectors
  • Inspection packagePart 11 matrix · SOC 2 alignment
  • SupportEmail · 24h response
Talk to sales
ENTERPRISE
Custom

Global programs, regulated cloud, custom DPA

Unlimited
Unlimited
  • Everything in Network
  • Dedicated infrastructureSingle-tenant deploy, your VPC peering
  • Co-author with our QAOur validation engineers in your packages
  • Custom DPA · MSANegotiated procurement terms
  • Regulatory liaisonDirect line to our regulatory affairs team
  • Dedicated regionsIncluding FedRAMP-aligned environments
Contact
02 — Compare

Every feature, side by side.

FeatureSiteNetworkEnterprise
AI Composer (multi-provider)
GAMP 5 phase-gated workflows
21 CFR Part 11 e-signatures
Append-only audit trail
DOCX · PDF · audit pack export
Managed systems25250Unlimited
Named users15UnlimitedUnlimited
Multi-tenant (Account ▸ Tenants)
Cross-tenant rollup reporting
Account-wide RBAC + custom roles
Custom approval workflows
Data residency (EU / US)
Dedicated infra / single-tenant
Co-authoring with our QA team
Custom DPA / MSA
03 — Procurement

Procurement-friendly answers.

Procurement-ready

Need a quote your CFO will accept? We'll co-write the business case.

30-minute call to size the program, scope the rollout, and align on procurement timing.