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.
The thesis
Why execution-time authorization is the piece the market is missing.
The VQP
Our Vendor Qualification Package — same format your team already uses.
The pilot
30-day pilot scope and the application form.
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:- The thesis (5 min)
- 21 CFR Part 11 mapping (5 min)
- Claims matrix (3 min)
- Pilot (2 min)