Autonomous AI · FDA Compliance

Compliance that never sleeps

CompliantMind autonomously monitors and maintains your FDA-regulated patient engagement portals — generating compliant content, detecting deviations in real time, and delivering structured reporting to stakeholders without human intervention.

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Built for pharma and med-tech teams navigating FDA 21 CFR Part 11, HIPAA, and the December 2024 AI-enabled device software guidance.

FDA 21 CFR Part 11

Electronic records and signatures compliance for pharma systems.

HIPAA

Patient data protection across digital engagement platforms.

AI-Enabled Device Software

December 2024 FDA draft guidance alignment for AI-driven patient tools.

Compliance Posture98.7%Portal uptime · This cycle

Trusted by quality and regulatory teams at life sciences organizations navigating:

21 CFR Part 11HIPAAFDA AI Device GuidanceGXP

Platform Capabilities

Every compliance task, all the time — without the humans.

CompliantMind acts as a tireless compliance agent, bridging patient-facing digital tools and regulatory obligation across your entire portfolio.

Autonomous Compliance Monitoring

Continuous, around-the-clock surveillance of your FDA-regulated patient portals — detects deviations before they become audit findings.

AI-Generated Compliant Content

Produce patient-facing materials that meet FDA 21 CFR Part 11 standards, with full documentation trails generated automatically.

Real-Time Deviation Detection

Instant alerts when patient engagement content drifts from approved templates or regulatory guardrails, with structured audit logs.

Stakeholder-Ready Reporting

Structured compliance reports built for quality teams, regulatory affairs, and external auditors — no manual assembly required.

How It Works

From integration to automated compliance — in three steps.

Connect Your Portals

Integrate CompliantMind with your existing patient engagement infrastructure. Our agent maps your content topology and learns your regulatory context.

Autonomous Monitoring Begins

CompliantMind continuously watches every patient touchpoint — surfacing issues in real time and logging every action for audit traceability.

Reports Delivered Automatically

Structured compliance reports arrive on schedule or on-demand, giving stakeholders a clear picture of compliance posture without manual work.

Live Demo

Run any patient-facing copy through the screen right now.

The same rules engine and structured LLM review CompliantMind runs on your live patient channels — exposed for visitors to try with their own copy (or one of the sample snippets below). Findings take a few seconds.

Try the compliance screen — live

Paste any patient-facing copy and CompliantMind runs two passes — a deterministic 21 CFR rules scan and an LLM review — and returns structured findings in under five seconds.

Try a sample

Patient-facing copy

0 / 5,000 chars · everything you paste stays in this request.

Ready to scale patient engagement without scaling compliance risk?

Talk to our team about integrating CompliantMind with your regulatory workflow. We'll walk you through a tailored compliance architecture.

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