The AI platform built to survive inspection.
Pharma, MedTech, and BioTech teams need answers a regulator will accept. CLAiRE is built from day one for that conversation — grounded in your data, double-checked before anyone sees the answer, and traceable down to the source record.
An AI that you can defend in an audit.
CLAiRE is not a chatbot. It is a platform with structure — workflows that follow your SOPs, agents grounded in your vocabulary, and gates that catch errors before they reach a human.
It runs your processes
Think of CLAiRE as the conductor that orchestrates every step of your compliance workflow — knowing what comes next, which experts to call on, and what to do if something goes wrong.
It reasons over your knowledge
One AI brain grounded in your organisation’s vocabulary — your controls, your deviations, your products. It cannot make up a term you have never defined.
It double-checks itself
Every AI answer is scored on a confidence band. Green proceeds, amber routes to a human, red is blocked. Nothing reaches the auditor on a guess.
It protects personal data
Personal data is replaced with safe tokens before any AI model sees it. The originals stay in your boundary — never shipped to a third-party provider.
It remembers in four ways
Permanent knowledge of your business. Memory of past decisions. A scratchpad for the current task. And a versioned library of how to do things. Together: cognition, not chat.
It watches itself, every day
CLAiRE monitors its own behaviour for drift, anomalies, and degraded models. It heals before customers notice — retry, swap models, escalate to a human, or simply pause.
Four kinds of memory. One coherent platform.
Most AI tools forget the conversation when you close the tab. CLAiRE has four memory tiers working together — so the platform can recall, reason, and reuse what it has learned.
Three commitments. Built into every product we ship.
You can see what the AI did
- A “Why” panel on every answer the AI produces
- Proof tree showing how the conclusion was reached
- Full conversation history with every supporting source
- Drift badge on every agent so you know it is fresh
- Replayable record of every run — for any auditor, any window
The system heals before you have to
- Automatic retries and model failover
- Approvals escalate up the chain when they sit too long
- Continuous compliance scans against seven control families
- Golden test cases on every agent — run on every save
- Auto-tuning learns from the failures it sees in production
Built for the auditor in the room
- Six roles, granted at the record level — no implicit access
- Tamper-evident evidence chain: every action signs the previous one
- Five-tier classification with attribute-based access control
- Four-layer guardrail against prompt injection and data exfiltration
- SOC 2 · ISO 27001 · ISO 42001 alignment
Five live. Three more on the way.
You do not buy a platform — you buy a working solution to a specific, expensive problem. Every appliance below is a product, not a feature. And every one inherits the same governance, evidence chain, and audit posture.
Migrate legacy quality data into your new QMS with a defensible audit trail.
A copilot that answers questions grounded in live Polarion requirements and traceability.
Continuous GxP audit-trail review — every event, every cycle, read-only by design.
Keep Veeva user records in sync with the source of truth. Spot drift the moment it appears.
Annual Product Quality Reviews in a day, not a month — with traceable provenance per paragraph.
IQ / OQ / PQ + GAMP 5 authoring and audit-export. Validation as a product.
NIST 800-53, ISO 27001, SOC 2, and NIST CSF — one continuous governance picture.
Ask anything of your enterprise data. See only what you are cleared to see.
From your question to a defensible answer.
Every request — whether it comes from chat, a workflow, or your own API call — moves through the same gates. Nothing reaches a human until each one has signed off.
You ask
Chat, build a workflow, or hit the API. The platform takes it from there.
CLAiRE grounds the question
Validates the request against your vocabulary; rejects anything that does not match your real data.
The right agent runs
Picks tools, anonymises personal data at the boundary, and reasons over your knowledge.
The answer is scored
Boolean rules and a second AI judge double-check the output. Green passes; amber escalates; red blocks.
Evidence is stamped
Every action chains to the previous one. The whole run is replayable for the next audit.
Cloud. On-prem. Or a turnkey appliance.
Same product, three shapes — pick the one that matches your security model.
CLAiRE Cloud
Multi-tenant, multi-region (US, EU, APAC), per-appliance subscription. We run the platform; you focus on quality. Every tenant gets its own database — no shared storage.
Enterprise
Runs entirely inside your infrastructure. Bring your own databases, message bus, identity provider, and even your own LLM. Air-gapped option available.
Single appliance
One appliance, one turnkey deployment. VM or Docker bundle, fewer surfaces to audit, simplest path to value.
Built by the people behind FDA CSA.
Compliance Group co-founded the FDA-Industry Computer Software Assurance team and contributed to the FDA CSA guidance. Twenty-five years inside audit rooms — now compiled into CLAiRE.