Six capabilities.
One platform that never stops watching.
Most compliance programs respond to problems. CLAiRE prevents them — with AI agents running continuously across every high-risk domain, from AI governance and CSA to data integrity, GRC, design control, and inspection readiness. Built by the team that co-authored the guidance.
AI governance, validation, data integrity, GRC, design control, and inspection readiness each have their own tools — and none of them talk to each other. CLAiRE is the first platform where all six capabilities share a single audit trail, a single evidence store, and a single AI governance layer.
The value of six capabilities running together.
Findings surface before they become observations
When data integrity, GRC, and inspection readiness share the same AI layer, CLAiRE can correlate signals across systems that no single tool would catch in isolation.
One audit trail covers every domain
Validation evidence, audit trail reviews, risk assessments, and policy attestations live in one sealed, tamper-evident record — not six separate binders assembled before each inspection.
Your team stops context-switching between tools
Quality leads, validation engineers, and compliance managers work from the same platform. No re-keying data between systems, no reconciliation before a review cycle.
Regulatory changes propagate automatically
When a new FDA guidance or EU GMP annex drops, CLAiRE flags the impact across all connected capabilities — so nothing falls through the gap between teams.
Select a capability to go deeper.
Each runs as a dedicated AI agent within CLAiRE — with its own SLA, its own evidence store, and full integration into your GxP stack. Together, they form a compliance program that never has an off day.
AI governance built before the FDA asks for it.
- ISO/IEC 42001-aligned AI governance framework
- AI system validation and CSA-aligned testing
- Explainable, traceable AI recommendations
- Continuous compliance intelligence via CLAiRE
Stop validating like it's 1997. CSA cuts validation time by 70%.
- Automated URS, FS, and DS drafting by risk class
- CSA-aligned critical thinking rationale — not templated
- Traceability review and completeness check before sign-off
- iQuality VX automates artifacts across the full lifecycle
Data integrity is the FDA's number one enforcement priority.
- 100% audit trail coverage — every record analyzed daily
- Cross-system intelligence across Veeva, LIMS, MES, eTMF
- User authorization cross-check automated in real time
- ALCOA+ compliance monitoring — systematic, not reviewer-dependent
Governance, Risk, and Compliance managed as one program — not four silos.
- CLAiRE continuous monitoring across all GRC domains
- Integrated compliance assessments replacing periodic audits
- AI-powered policy and risk management, CMDB integrated
- Single source of truth for risk, policy, and audit findings
Design Control built for audit — not built around the audit.
- Polarion-based design control implementation (Siemens partner)
- ISO 14971 risk management programs for MDR/IVDR
- CLAiRE AI quality reviews for design documentation
- Automated traceability from requirements to test evidence
Continuous inspection readiness — the auditor never catches you off guard.
- Zero major audit observations — no-cost remediation guarantee
- CLAiRE continuous ATR coverage, 100% records analyzed
- Pre-inspection preparation and evidence assembly in minutes
- Post-inspection response with structured CAPA tracking
Built on the guidance we helped write — and the 300+ systems we've validated.
No other compliance AI platform was built by FICSA co-founders, trained on a 300+ GxP system knowledgebase, and independently certified under ISO/IEC 42001. That combination is why CLAiRE's outputs hold up under FDA scrutiny where others don't.
Regulatory authorship, not interpretation
Compliance Group co-founded FICSA and co-authored GAMP 5 Second Edition. CLAiRE was designed from the inside of the regulatory conversation — not reverse-engineered from published guidance.
Cross-domain intelligence by design
Because all six capabilities share one platform, CLAiRE can surface correlations a point solution never sees — a data integrity signal that predicts an inspection finding before it's written.
Every output is audit-defensible
ISO/IEC 42001 certification means every AI recommendation carries a sealed provenance record. When the auditor asks "how did you reach that conclusion?" — CLAiRE already has the answer prepared.
ISO/IEC 42001:2023 · SOC 2 Type 2 · ISO/IEC 27001:2022
ISO/IEC 42001:2023 Certified
The only ISO/IEC 42001-certified AI Management System in life sciences compliance. Every AI recommendation is explainable, traceable, and audit-ready.
SOC 2 Type 2 Compliant
Independently audited controls. Proven operational effectiveness. Security, availability & confidentiality assured.
ISO/IEC 27001:2022 Certified
International information security standard. Risk-based security management. Strong data protection for regulated environments.
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