> ## 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.

# For Biotech CCOs

> A short, honest read for Chief Compliance Officers and Quality leads at biotech and pharma companies evaluating AtlaSent.

<Note>
  This section is written for Chief Compliance Officers, Heads of Quality, Validation Leads, and the people they forward URLs to. It assumes familiarity with GxP but **not** with AtlaSent or AI agents in general.
</Note>

Three things you probably want first:

<CardGroup cols={3}>
  <Card title="The thesis" icon="lightbulb" href="/biotech/thesis">
    Why execution-time authorization is the piece the market is missing.
  </Card>

  <Card title="The VQP" icon="file-contract">
    Our Vendor Qualification Package — same format your team already uses.
  </Card>

  <Card title="The pilot" icon="handshake">
    30-day pilot scope and the application form.
  </Card>
</CardGroup>

## What AtlaSent is, in one paragraph

AtlaSent is **execution-time authorization for AI agents in GxP environments**. When an AI agent in your stack wants to take a consequential action — write to an EHR, release a batch, modify a trial record — it calls AtlaSent first. AtlaSent checks the action against a RACI policy your Quality team authored, returns one of the canonical four-value decisions (`allow` / `deny` / `hold` / `escalate`) in milliseconds, and writes a tamper-evident audit entry. Every decision is signed; the audit chain is exportable as evidence for FDA or EMA inspection.

## What it isn't

* **Not a medical device.** AtlaSent is a SaaS platform, not a medical device. Using it with medical-device software requires your own separate assessment.
* **Not an AI model.** We do not train or fine-tune. AtlaSent has no access to patient data unless you explicitly log a target ID — and we strongly recommend you do not.
* **Not a replacement for your QMS.** AtlaSent authorizes agent actions; your QMS still governs your SOPs, CAPAs, and deviation handling. AtlaSent feeds signals into both.

## What we can honestly claim today

The claims matrix is the canonical, dated record of what AtlaSent is aligned with, partially aligned with, or explicitly not aligned with. If a claim appears anywhere else that isn't reflected on that page, the other copy is wrong.

Short version: **Aligned** for 21 CFR Part 11, EU Annex 11, ALCOA+, GxP change control. **Supported** for ICH E6 GCP, ISO 27001, GDPR. **On roadmap** for SOC 2 Type II. **Not yet available** for HIPAA BAA.

## If you have 15 minutes

Read in this order:

1. [The thesis](/biotech/thesis) (5 min)
2. [21 CFR Part 11 mapping](/compliance/21-cfr-part-11) (5 min)
3. Claims matrix (3 min)
4. Pilot (2 min)

Then email [pilot@atlasent.io](mailto:pilot@atlasent.io) with the frameworks that matter to your program. We'll reply with the VQP pre-filled for your environment.


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