Documentation — ComplianceSuite

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

Getting started

Provision an Account, place your first Tenant, and understand who can do what.

Quickstart for validation managersCS-DOC-0001Provision an Account, create your first Tenant, and ship a change end-to-end. Email + password onboarding, no SSO required.PDF · 12 pp ↓
Concepts: Account · Tenant · System · ChangeCS-DOC-0002How the four-level hierarchy maps to your real organisation, with the data model and access boundaries that back it.PDF · 18 pp ↓
Roles and permissionsCS-DOC-0003Account-, tenant-, and change-level roles. Pre-built role catalogue, RBAC primitives, and how to compose your own permission sets.PDF · 8 pp ↓

Authoring

Multi-provider AI Composer plus a generic, structured template system.

Validation workflows

GAMP 5 phase model, Separation-of-Duties enforcement and periodic review.

Compliance documentation

How the implemented audit and signature primitives meet 21 CFR Part 11 and EU GMP Annex 11 today.

Reference matrices

Pre-mapped control matrices and lifecycle map you can hand to inspectors.

Implementation

Need a real engineer? Our team is one message away.

Site and Network customers get a named validation manager — not a ticket queue. Bring a real change request to the demo and we'll draft your URS live.

+ Book a demo Browse the validation library

Platform docs, written by humans.