Built for the industries where compliance is the product.
CLAiRE is not a general-purpose AI platform retrofitted for life sciences. It is built from the ground up for Pharma, MedTech, BioTech, and CDMOs — and every architectural decision reflects what FDA, EMA, and notified-body auditors actually inspect.
Where CLAiRE is deployed today.
Pharmaceutical Manufacturers
GMP-regulated drug substance and drug product manufacturers. Active CAPA programs, recurring APQR cycles, complex multi-site change control. CLAiRE reduces APQR cycle time, automates audit-trail review, and provides defensible CSA documentation.
Medical Device Manufacturers
21 CFR 820, ISO 13485, IEC 62304-regulated device manufacturers. Design controls, risk management (ISO 14971), complaint handling. CLAiRE accelerates QMS migrations between TrackWise / MasterControl / Veeva, automates audit-trail review, and produces evidence packs ready for FDA inspection.
Biotechnology & Cell/Gene Therapy
Advanced therapies, biologics, and cell/gene therapy manufacturers. Tight batch traceability, comparability evidence, and cross-functional change control. CLAiRE's evidence chain and per-batch provenance is built for the data-density modern biologics demand.
Contract Development & Manufacturing
Multi-customer quality systems with strict data segregation. Per-customer audit packs. CLAiRE's 5-tier data classification and ABAC let you serve every customer from one tenant without bleed-through, and produce customer-specific APQRs on demand.
Diagnostics, IVDs, and Healthcare Providers
CLIA-, FDA-, and EU IVDR-regulated diagnostic manufacturers, plus hospital QMS programs. CLAiRE's read-only audit-trail review and continuous compliance monitoring fit environments where production data must never leave the tenant boundary.
Designed against the standards your auditors quote.
Compliance Group executives co-founded the FDA-Industry Computer Software Assurance Team (FICSA) and contributed to the FDA CSA guidance. Twenty-five years inside audit rooms — now compiled into how CLAiRE thinks about evidence, change control, and validation.
Sensitive data goes only where you say it can.
Roles alone are not enough. CLAiRE classifies every record on a five-tier scale and applies access rules based on who is asking, what they are cleared for, when, and from where — closing data-leakage gaps that role-based access on its own cannot.
Enforced at every step — when a question is asked, when a tool returns a result, when the AI reads from your knowledge base, and again before any answer leaves the platform.
Cloud. On-prem. Or a turnkey appliance.
Regulated buyers do not all live in the cloud. Pick the shape that matches your security model — the product underneath is identical.
Multi-tenant SaaS
We run it; you focus on quality. Available in US, EU, and APAC regions. Every tenant gets its own database — no shared storage.
On-prem, in your network
Runs entirely inside your infrastructure. Bring your own databases, identity provider, and even your own AI model. Air-gapped option available.
Single-appliance turnkey
One appliance, one deployment. VM image or Docker bundle. The simplest path to value — and the smallest audit surface.
Talk to people who've been on the regulator's side of the table.
Our team includes ex-FDA inspectors, FICSA contributors, and 25-year Quality SMEs. Bring us your hardest audit-readiness problem.