Documents · Validation · Quality · ISO/IEC 42001 Certified · Deploys in Weeks
The AI-native QMS that deploys in weeks,
not 18 months.
iQuality is an AI-native quality and compliance platform built from the ground up for regulated life sciences. Three modules — Document Xcellence (DX), Validation Xcellence (VX), and Quality Xcellence (QX) — all built under the only ISO/IEC 42001-certified AI Management System in life sciences compliance. Trusted by leading life sciences regulated organizations.
The QMS Paradox
Legacy QMS platforms cost $1M+ and take 12–18 months to implement. iQuality deploys in weeks because it was designed for life sciences from day one — not adapted from an enterprise workflow tool with compliance features bolted on. And CLAiRE AI Agentic Platform is embedded in every module from the start.
Weeks
Typical deployment time
vs. 12–18 months for legacy QMS implementations
40–70%
Reduction in validation effort
iQuality VX + CLAiRE AI Agentic Platform vs. manual CSA validation
~60%
Effort reduction with CLAiRE
Across all validation phases — conservative estimate
ISO 42001
AI governance certified
Only certified AI MS in life sciences compliance
What success looks like
What compliance looks like when your QMS works with your team — not against them.
Your next inspection is a non-event
Evidence assembled in minutes. AI governance framework documented and defensible before the auditor asks.
Your compliance scales with your business
Expert judgment embedded in systems — not trapped in 2–3 people who could leave.
Your quality team operates compliance — not proves it
Continuous assurance replaces the quarterly audit scramble. Best people focus on what matters.
You have one partner who sees the whole picture
Strategy through staffing through managed services through AI tools — one trusted partner, not five vendors.
Three modules. Start with what hurts most.
Document Xcellence· Validation Xcellence· Quality Xcellence
Each iQuality module deploys independently. Start with your biggest pain — add modules as your program grows. CLAiRE AI Agentic Platform is embedded across all three, governed under ISO/IEC 42001.
DX
Document Xcellence
AI-assisted document authoring, change impact analysis, 21 CFR Part 11-compliant e-signatures, document lifecycle management, and SOP governance. CLAiRE Quality Reviews automatically check documents for completeness and traceability.
30–50%
Reduction in document cycle time
VX
Validation Xcellence
CSA-aligned validation execution, automated artifact generation (URS, IQ/OQ/PQ, traceability matrices), risk-based testing frameworks. CLAiRE Validation Doc Generator reduces protocol creation by 23% and Review & Approval by 40%.
40–70%
Reduction in validation effort
QX
Quality Xcellence
AI-driven CAPA management, deviation handling, change control, risk management, and predictive quality signals. CLAiRE Continuous Monitoring feeds deviations directly into QX for immediate CAPA initiation — closed-loop quality from detection to resolution.
60%+
Reduction in CAPA cycle time
The CLAiRE AI Agentic Platform — embedded in every module
360-degree compliance on one certified platform.
CLAiRE AI Agentic Platform isn’t an add-on to iQuality — it’s the intelligence layer embedded across DX, VX, and QX. 360-degree compliance, all governed under ISO/IEC 42001.
Validation Doc Generator
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.
Audit Trail Review (ATR)
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.
Quality Reviews
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.
Integrated Compliance Assessments
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.
Continuous Monitoring
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.
MAiGRATE Integration
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 AI efficiency by validation phase
Where CLAiRE AI Agentic Platform delivers the biggest gains.
Conservative efficiency estimates based on CG delivery experience across MSP engagements supporting 60+ regulated organizations.
|
Validation Phase |
Effort Today |
With CLAiRE |
Est. Savings |
|---|---|---|---|
|
Planning & Risk Assessment |
10% |
7% |
30% |
|
Requirements & Traceability |
20% |
15% |
25% |
|
Protocol Creation & Execution |
35% |
27% |
23% |
|
Review & Approval |
20% |
15% |
40% |
|
Reporting |
10% |
7% |
30% |
|
Overall Savings |
100% |
71% |
~29% |
Two entry points. One platform.
Which situation is yours?
Already Have a QMS Stack?
Add intelligence on top. No rip-and-replace.
Veeva, MasterControl, or other established platforms
- CLAiRE AI Agentic Platform: Audit Trail Review, Continuous Monitoring, and Compliance Assessments on top of your existing validated stack
- iQuality QX: CAPA and quality management integrated with your existing platforms
- CLAiRE Agentic AI Studio: build custom AI agents for your specific workflows, no code
Start with CLAiRE ATR → add Continuous Monitoring → evaluate iQuality QX for CAPA
Building from Scratch or Replacing?
Start with the module that addresses your biggest pain.
No QMS / replacing legacy / building from ground up
- iQuality DX: fastest ROI — document cycle time reduction starts immediately
- iQuality VX: biggest effort reduction — validation in weeks, not months
- iQuality QX: complete quality management with closed-loop CLAiRE monitoring
Start with DX pilot → expand to VX → add QX → full platform with CLAiRE AI Agentic Platform
iQuality is built and deployed by the same CG team. Every iQuality implementation reveals Strategic Consulting opportunities (gaps in the compliance architecture), Managed Services needs (ongoing platform governance), and opportunities to extend CLAiRE AI Agentic Platform capabilities as the program matures.
Years in quality & compliance
Regulated client organizations
Projects delivered globally
Client revenue generated
Certifications
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.
Your next move
Book a free AI Readiness 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.