> ## Documentation Index
> Fetch the complete documentation index at: https://docs.elevatedsignals.ai/llms.txt
> Use this file to discover all available pages before exploring further.

# Compliance & Validation overview

> How Invariant supports your validation and regulated use.

Invariant is built to **21 CFR Part 11** and **EU Annex 11** expectations and is designed to support
your intended-use validation under a **shared-responsibility model**:

* **Elevated Signals** qualifies the platform — infrastructure, data segregation, audit integrity, and
  the shipped verification tooling.
* **Your organization** validates its configured intended use (risk-based, aligned to FDA CSA).

<Note>
  Invariant is **not** represented as GMP compliant, Part 11 certified, or fully validated on your
  behalf. These pages describe tested product behavior and provide evidence to accelerate *your*
  validation — they are not a compliance certification.
</Note>

## The Validation Accelerator Pack

A ready-to-use set of documents — intended-use statement, GAMP 5 categorization, Part 11/Annex 11
matrix, risk-assessment and OQ templates, and technical statements for audit integrity, tenant
isolation, and data integrity — designed to substantially reduce your validation effort.
See [Validation Accelerator Pack](/invariant/compliance/validation-accelerator-pack).

## Start here

<CardGroup cols={2}>
  <Card title="Audit trail & tamper-evidence" href="/invariant/compliance/audit-trail-tamper-evidence" icon="link" />

  <Card title="Part 11 / Annex 11" href="/invariant/compliance/part-11-annex-11" icon="scale-balanced" />

  <Card title="Multi-tenant data segregation" href="/invariant/compliance/multi-tenant-data-segregation" icon="server" />

  <Card title="Data integrity (ALCOA+)" href="/invariant/compliance/data-integrity-alcoa" icon="database" />
</CardGroup>