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

# Compliance

> Which regulatory frameworks AtlaSent aligns with, and where to verify each claim.

AtlaSent is designed for GxP-regulated environments. The compliance docs are organized around one rule: **every claim points to a product primitive that satisfies the requirement**. No hand-waving.

## Start here

<Card title="Compliance status" icon="shield-check" href="/trust/compliance-status">
  What AtlaSent is aligned with, partially aligned with, and explicitly not aligned with.
</Card>

## Framework deep-dives

<CardGroup cols={2}>
  <Card title="21 CFR Part 11 (FDA)" icon="flask" href="/compliance/21-cfr-part-11" />

  <Card title="EU Annex 11 (EMA)" icon="syringe" href="/compliance/eu-annex-11" />

  <Card title="ALCOA+" icon="list-check" href="/compliance/alcoa-plus" />

  <Card title="ICH E6 GCP" icon="flask-vial" href="/compliance/ich-e6-gcp" />

  <Card title="GxP change control" icon="code-branch" href="/compliance/gxp-change-control" />
</CardGroup>

## Not-yet-available

AtlaSent is honest about gaps. The [compliance status](/trust/compliance-status) page explicitly lists:

* **SOC 2 Type II** — not yet started; see [Compliance status](/trust/compliance-status).
* **HIPAA BAA** — not yet available; contact sales.
* **FDA 510(k)** — N/A; AtlaSent is not a medical device.
* **EU AI Act** — in evaluation; pre-review mapping available on request.

If you need a claim that isn't here, ask before assuming.


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