Your GxP systems should scale expert judgment,
not just record decisions.
Compliance Group's proprietary AI products are built on 25 years of GxP expertise and governed under the only ISO/IEC 42001-certified AI Management System in life sciences compliance. Trusted by 60+ regulated life sciences organizations. They don't replace your quality team. They give your quality team leverage.
Three integrated products. One architecture. CLAiRE thinks. MAiGRATE provides context. iQuality ensures trust. All governed under the only ISO/IEC 42001-certified AI Management System in life sciences compliance. Together: the complete AI-native compliance stack.
One secure platform. Many AI solutions. Every output audit-ready.
CLAiRE AI Agentic Platform is Compliance Group's proprietary intelligence engine — trained on an ISO 13485:2016 ontology for life sciences and governed under ISO/IEC 42001. Every CLAiRE AI Agent resolves a specific pain point, together delivering 360-degree compliance coverage on one certified platform.
AI-Powered Validation Documentation
Automated generation of contextual validation lifecycle documentation: URS, FS, DS drafting, completeness review, and traceability checking aligned to CSA principles. Up to 25% reduction in documentation effort.
Continuous Data Integrity Assurance
From reactive quarterly sampling to 100% continuous audit trail coverage. Every record analyzed daily. User training and authorization cross-checked automatically. Regulator-ready findings reports. Replaces the 90-day blind window.
AI-Powered Validation Document Review
Automated review of validation documents for completeness, accuracy, and traceability against requirements. Reduces review and approval cycle time by up to 40%, the highest-savings phase in the validation lifecycle.
GxP · Part 11 · SOX · Cybersecurity
AI-powered compliance assessment generation across GxP, 21 CFR Part 11, SOX, and Cybersecurity frameworks. Structured, audit-defensible assessment outputs, generated in hours, not weeks.
Deviation Detection Against Corporate Procedures
AI-powered continuous review of quality records to identify deviations against corporate procedures, before they become findings. Real-time Microsoft Teams alerting when anomalies surface.
CSA-Aligned Test Case Generation
Automated generation of CSA-aligned test cases with up to 70% total effort reduction. Integrates natively with Siemens Polarion. Consistent, audit-defensible test coverage without the manual build.
Automated Access Governance
AI-powered review of user access across regulated systems, flagging unauthorized or expired permissions before they become audit findings. Reduces manual review effort and closes a common inspection gap.
AI-Powered Data Migration & Verification
Integrated regulated data migration and verification platform for accelerated platform transitions, from Jama, DOORS, legacy QMS, and more. Audit-defensible documentation at every step. See MAiGRATE.
CLAiRE thinks. MAiGRATE provides context. iQuality ensures trust.
CLAiRE AI Agentic Platform
Six AI capabilities on one certified platform: Validation Doc Generator, Audit Trail Review (100% daily), Quality Reviews (40% effort reduction), Integrated Compliance Assessments (GxP, Part 11, SOX, Cybersecurity), Continuous Monitoring, and MAiGRATE data migration. CLAiRE Agentic AI Studio lets you build AI agents visually, no code. All governed under ISO/IEC 42001.
See CLAiRE AI Agentic PlatformMAiGRATE
Part of CLAiRE AI Agentic Platform. Organizes regulated data so AI can trust what it uses. Automated migration from Jama, DOORS, Codebeamer, Word/Excel DHFs, and legacy QMS platforms, with audit-defensible documentation at every step, governed under ISO/IEC 42001.
See MAiGRATEiQuality
The GxP trust and compliance layer where CLAiRE AI intelligence becomes audit-ready evidence in regulated workflows. Document Excellence (DX), Validation Excellence (VX), Quality Excellence (QX). Deploys in weeks. 20+ API integrations. CLAiRE embedded across all three modules.
See iQualityWhere CLAiRE AI Agentic Platform delivers the biggest gains.
Conservative efficiency estimates based on Compliance Group delivery experience across MSP engagements with 60+ regulated life sciences organizations.
| Phase | Est. Savings |
|---|---|
| Assessments | 70% |
| Validation | 60% |
| Quality Reviews | 55% |
| Data Migration | 60% |
| Periodic Reviews | 60% |
| Quality Management Reviews | 50% |
| Change Controls | 65% |
| Overall Savings | ~60% |
Which situation describes your organization?
Add intelligence on top. No rip-and-replace.
- CLAiRE AI Agentic Platform: Audit Trail Review (100% daily) + Continuous Monitoring on top of your existing validated stack
- Integrated Compliance Assessments: GxP, Part 11, SOX, Cybersecurity: hours not weeks
- CLAiRE Agentic AI Studio: build custom AI agents for your specific workflows, no code
Start with the module that addresses your biggest pain.
- iQuality DX: fastest ROI, document cycle time reduction starts immediately
- iQuality VX: biggest effort reduction — CLAiRE Validation Doc Generator + Quality Reviews
- iQuality QX + CLAiRE Continuous Monitoring: closed-loop quality from deviation to CAPA
The certification stack behind every Compliance Group product.
ISO/IEC 42001:2023 Certified
Only ISO/IEC 42001-certified AI Management System in life sciences compliance. Every CLAiRE AI Agentic Platform output is explainable, traceable, and audit-ready.
SOC 2 Type 2 Compliant
Independently audited controls. Security, availability & confidentiality assured for all Compliance Group systems and client data.
ISO/IEC 27001:2022 Certified
International information security standard. Risk-based security management. Strong data protection for regulated environments.
Book a Free Assessment.
45 minutes with a senior expert, not a sales rep. Written risk brief included. No commitment. You walk away knowing exactly where your biggest regulatory exposure sits.
Book Your Free Assessment