Know Your AI Compliance Exposure
In 10 Working Days
The 8-area GAMP AI maturity model. Covers EU GMP Annex 22, GAMP 5 AI Guide, and EU AI Act High Risk obligations in a single report.
The Only Gap Report Covering All Three Frameworks
Most AI compliance reviews cover one framework. Ours covers all three simultaneously: ISPE GAMP AI Guide (2025), EU GMP Annex 22 (now in force), and EU AI Act High Risk classification (enforcement August 2026).
The report quantifies your current penalty exposure (up to €30M or 6% of global annual turnover for High Risk AI non-compliance), scores each of the 8 compliance areas, and delivers a prioritised remediation plan with clear timelines.
- Delivered to a fixed timeline
- Timeline: 10 working days from kick-off
- Delivery: Written report + executive presentation
- Coverage: All AI/ML systems in scope
- Frameworks: Annex 22 · GAMP AI Guide · EU AI Act
- Head of Quality / VP Quality
- CSV Lead / Validation Manager
- Regulatory Affairs Director
- CTO / CISO (AI product companies)
- Medical device manufacturers with AI
- Pharma facilities using AI for batch release, PV or visual inspection
8-Area AI Compliance Maturity Model
Data Governance
Training data quality · Lineage · ALCOA+ · Data drift monitoring
Model Validation
URS · Protocol · Pre-defined acceptance criteria · IQ/OQ/PQ
Change Control
Model versioning · SHA-256 hashing · Revalidation triggers
Ongoing Monitoring
Performance monitoring · Concept drift · Production surveillance
Risk Classification
GAMP 5 AI category · EU AI Act High Risk assessment
Governance
AI oversight · Roles & responsibilities · Policy documentation
Supplier Management
Vendor qualification · Audit rights · Contracts · SLAs
Post-Market Surveillance
Ongoing compliance · EU AI Act post-market reporting obligations