Clinivion

Your FDA audit shouldn't
keep you up at night.

Nessa automates pharmaceutical data integrity so you can focus on the science.

nessa.clinivion.com | edem@clinivion.com

$2.5B+
Lost annually to data integrity failures across pharma
65%
Of FDA 483 observations cite data integrity gaps
12-18 mo
Average approval delay after a warning letter
What Nessa replaces
Spreadsheet-based audit trails → Tamper-proof, cryptographically verified records
Unencrypted sensitive data → Military-grade field-level encryption
Manual compliance checks → Automated ALCOA+ validation in real-time
Reactive quality reviews → AI that catches anomalies before auditors do
Paper signatures → FDA-compliant electronic signatures
Siloed access controls → Role-based permissions across your entire team
How it works
1
Connect
Integrates with your existing lab systems in days, not months
2
Protect
Every data point gets an immutable proof of integrity
3
Prove
One-click audit reports when the FDA walks in
Start with a $10,000 Proof of Concept
30 days, fully credited toward your annual contract. No risk. No long procurement cycle.
Watch the 2-minute product demo →
Compliance coverage
FDA 21 CFR Part 11 ALCOA+ GAMP 5 ISO 27001 GDPR HIPAA
How Nessa compares
Nessa Veeva Vault MasterControl
Annual cost $75K -- $250K $500K+ $200K+
Time to deploy Days 6-12 months 3-6 months
Tamper-proof audit trails ✓ ✗ ✗
AI anomaly detection ✓ ✗ ✗
Built for biotech scale ✓ Enterprise only Enterprise only
Who it's for
VP Regulatory Affairs
Stop worrying about 483 observations. Nessa gives you audit-ready proof at all times.
Head of Quality
Replace manual SOPs with automated compliance that scales with your pipeline.
CTO / Chief Data Officer
Modern infrastructure that passes technical due diligence from both FDA and investors.
Built on technology trusted by
AWS Google Redis
Under the hood

Nessa runs on AWS infrastructure with Rust for memory-safe, high-performance processing and PostgreSQL for enterprise-grade data reliability. Cryptographic integrity is powered by the same Certificate Transparency framework that Google developed to secure the internet's public key infrastructure. Encryption uses AES-256-GCM — the same standard used by the US Department of Defense. Digital signatures use ED25519, the algorithm behind Signal and SSH. Caching and real-time operations run on Redis, trusted by Twitter, GitHub, and Stripe.

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