QualityMind is the AI-powered QMS built for European biotech. Full EU GMP Annex 11 + FDA 21 CFR Part 11 compliance. Self-hosted AI — your data never leaves your infrastructure. From €5K/year.
The status quo is broken. Here's what we hear from teams like yours.
A €20M Series A shouldn't spend €100K/year on QMS — that's a senior scientist's salary. Every euro on systems is a euro not spent on your clinical program.
US-hosted QMS platforms put your data under the Cloud Act — not GDPR. Your SOPs, deviations, and audit trails are subject to US government access.
Most QMS platforms bolt on AI as a chatbot. None understand EU GMP and FDA simultaneously. None detect conflicts between jurisdictions.
Six integrated modules. One platform. Built specifically for clinical-stage European biotech.
Full lifecycle management. Draft, Review, Approve, Effective, Periodic Review. Version control with complete audit trails.
Assignments, quizzes, certificates, and curriculum tracking. Ensure every team member is qualified for their role.
Deviations, CAPAs, OOS/OOT investigations. Root cause analysis and trend detection with AI assistance.
AI pre-fills from uploaded documents. Built-in risk assessment. Track changes from initiation through closure.
Multi-jurisdiction analysis. EU GMP Annex 11, FDA 21 CFR Part 11, and ICH Q10. Cross-document contradiction detection with direct quotes.
21 CFR Part 11 compliant. Re-authentication with meaning declaration. Full audit trail for every signature.
Not a chatbot. A compliance engine trained on regulatory frameworks that actually understands multi-jurisdiction requirements.
AI finds specific conflicts between your SOPs, policies, and work instructions — with direct quotes from both documents. No more manual traceability matrices.
Analyzes against EU GMP Annex 11, FDA 21 CFR Part 11, and ICH simultaneously. One document, three regulatory checks.
Automatically flags when EU requires X but FDA requires Y. No other QMS does this.
Upload a vendor notification or audit finding. AI extracts title, classification, risk, impact, and suggested actions automatically.
Mistral runs on our own EU GPU infrastructure. Your documents never leave your environment. No third-party API calls. Full data sovereignty by default.
One document checked against three regulatory frameworks simultaneously.
Select a document — SOP, policy, or work instruction
AI checks EU GMP, FDA, and ICH — scores each framework
Review by jurisdiction — accept, flag, or re-run
Upload a vendor release note or audit finding. AI reads it and pre-fills your change request.
Upload a document — vendor notification, CAPA, or regulatory change
AI pre-fills the form — title, risk, classification, impacted SOPs
You review and approve — AI assists, you decide
The only platform that's simultaneously sovereign and AI-powered.
| QualityMind | Montrium Connect | SimplerQMS | Veeva Vault | |
|---|---|---|---|---|
| AI Compliance Engine | ✓ Multi-jurisdiction | ✗ None | ✗ None | ✗ None |
| Swedish / EU Hosting | ✓ Sweden + Finland | ✗ Canada / Azure | ⚠ EU (M-Files) | ✗ US (AWS) |
| AI Data Sovereignty | ✓ Self-hosted, no 3rd party | ✗ No AI | ✗ No AI | ✗ No AI |
| EU GMP Focus | ✓ Primary | ✓ Yes | ✓ Yes | ✓ Yes |
| Contradiction Detection | ✓ Cross-document + cross-jurisdiction | ✗ | ✗ | ✗ |
| Annual Cost | From €5K | €50–100K+ | €15K+ | €150K+ |
We're onboarding a small group of design partners in 2026. Request early access and help shape the product.
Thanks for your interest. We'll reach out within 48 hours to discuss next steps.
We're recruiting experienced QA professionals as early advisors. If you've managed QMS implementations, survived MPA or FDA audits, or just have strong opinions about what a modern QMS should be — we want to hear from you.
Become an Advisor →