Data Integrity,
Automated.
Nessa brings real-time ALCOA+ validation, cryptographic audit trails, and regulatory compliance to every research record — without the overhead.
Manual compliance costs pharmaceutical companies an average of $19M per delayed drug approval. Your data integrity process shouldn't be the bottleneck.
FDA 483 observations. Failed audits. Data integrity violations. They're all symptoms of the same problem — compliance as an afterthought.
of FDA warning letters cite data integrity as the primary violation
average cost per drug approval delay due to compliance failures
more audit findings in organizations without automated audit trails
Everything compliance.
Nothing you don't need.
Purpose-built for pharmaceutical data integrity, not retrofitted from generic software.
ALCOA+ Validation Engine
Real-time validation against all 9 ALCOA+ principles — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available. Every record, every time.
Cryptographic Audit Trail
Merkle tree proofs and Certificate Transparency logs ensure every record is tamper-evident and immutable.
Immutable Audit Trail
Every action logged with WHO, WHAT, WHEN, WHERE, and WHY. Append-only, encrypted, and always available for inspection.
ED25519 Digital Signatures
CFR Part 11-compliant electronic signatures using ED25519 cryptography. Every signature is verifiable, attributable, and legally binding. Full MFA support with biometric options for mobile.
ML-Powered Risk Scoring
Machine learning anomaly detection flags data integrity risks before they become violations. Logistic regression models trained on pharmaceutical-specific patterns.
Enterprise Multi-Tenancy
Schema-based PostgreSQL isolation ensures complete data separation between studies, sponsors, and organizations. Fully RBAC-controlled with 5 permission tiers.
Compliance in three steps.
Not three months.
Connect
Integrate Nessa with your existing LIMS, ELN, eCRF, and data systems via REST API or pre-built connectors. Under 30 minutes to first record.
Validate
Every record is automatically validated against FDA 21 CFR Part 11, EMA ALCOA+, and ICH GCP requirements in real time — under 50ms per record.
Prove
Cryptographic Merkle proofs and Certificate Transparency logs generate audit-ready evidence. Walk into any FDA inspection with confidence.
Built for every major framework.
Nessa doesn't bolt compliance on after the fact. Every feature is designed from first principles around regulatory requirements. One platform, every major framework.
Request compliance matrix →Transparent pricing.
No compliance surprises.
Annual contracts. All plans include full ALCOA+ validation, cryptographic audit trails, and digital signatures. Implementation included.
Phase I–II biotech teams launching their first compliant studies.
- Up to 50 users
- Up to 5 active studies
- 100 GB storage
- Full ALCOA+ validation
- Cryptographic audit trail
- 99% uptime SLA
- ML risk scoring
Phase II–III biotech scaling across multiple concurrent studies.
- Up to 200 users
- Up to 25 active studies
- 500 GB storage
- ML-powered risk scoring
- IoT sensor integration
- Priority support + 99.9% SLA
- Multi-year discount available
Large pharma, CROs, and regulated manufacturing at scale.
- Unlimited users & studies
- Unlimited storage
- Dedicated AWS environment
- IQ/OQ/PQ documentation
- Dedicated CSM + TAM
- 99.95% SLA + custom terms
All plans billed annually. 10% discount for 2-year · 15% for 3-year contracts. Multi-entity licensing available.
Start with a 30-day Proof of Concept.
We charge $10,000 for a 30-day implementation and gap analysis — credited 100% toward your annual contract. You'll have a live ALCOA+ audit trail, a full compliance gap report, and FDA-ready evidence before the engagement ends.
$10,000 · 30 days · Credited toward annual contract · Limited to 3 spots per quarter.