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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.

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Start here

Compliance status

What AtlaSent is aligned with, partially aligned with, and explicitly not aligned with.

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Framework deep-dives

21 CFR Part 11 (FDA)

EU Annex 11 (EMA)

ALCOA+

ICH E6 GCP

GxP change control

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Not-yet-available

AtlaSent is honest about gaps. The compliance status page explicitly lists:
  • SOC 2 Type II — not yet started; see 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.