Nessa ships with a complete validation package. Your QA team executes pre-built protocols, reviews the automated evidence report, and signs off. What takes 6–12 months with other vendors takes 1–2 weeks with Nessa.
The current approach to CSV/CSA is broken. It drains budgets, stalls deployments, and leaves data integrity gaps wide open.
Traditional validation requires hiring specialized consultants to write protocols, execute tests, and compile evidence. The cost is staggering and unpredictable.
Your QA team writes protocols from scratch, hires consultants, and manually tests every feature. Deployments stall while paperwork piles up.
While you wait for validation to finish, your systems run unvalidated. FDA inspectors find gaps. 483s get issued. The risk compounds daily.
Everything your QA team needs to validate Nessa against FDA 21 CFR Part 11 and EU Annex 11 requirements. No consultants required.
Every requirement traced from business need to code implementation and test case.
Operational Qualification protocols covering all critical system functions, with 45 cases fully automated.
One command generates the complete evidence package: screenshots, logs, checksums, and a signed PDF report.
Ready-to-adopt SOPs covering system use, data entry, audit review, electronic signatures, and more.
FMEA-based risk assessment covering every system function, with severity, occurrence, and detection ratings.
Every requirement linked to its design specification, test case, and evidence. 100% bidirectional coverage.
Clause-by-clause compliance mapping showing how Nessa satisfies each Part 11 requirement.
Pre-built templates for deviation reports, CAPA tracking, and training records. Customize with your branding.
The final validation report is SHA-256 hashed and digitally signed, providing tamper-evident proof of execution.
No consultants. No months of waiting. Deploy, run, sign off.
Install Nessa in your validated infrastructure—cloud, on-premise, or hybrid. Our team handles deployment if needed.
Execute the automated validation runner against your instance. It tests every critical function and generates the evidence package.
node validation-runner.js --url your-nessa.com --license YOUR_KEY
Your quality team reviews the generated report, verifies the evidence, and signs off. Validation complete. You're FDA-ready.
Both tiers include 1 year of updates and re-validation support on upgrades.
Your QA team runs the validation. We provide everything they need — protocols, automation, SOPs.
Veridatum, an independent validation consultancy, executes the full qualification on-site. Turnkey, from deployment to signed report. No conflict of interest.
Pricing is per-instance. Multi-site and enterprise licensing available upon request.
See why leading pharma companies are switching to pre-validated platforms.
| Traditional Validation | Nessa Validated | |
|---|---|---|
| Timeline | 6–12 months | 1–2 weeks |
| Consulting Cost | $150K–$300K | $0 (included) |
| Test Automation | 0% automated | 68% automated |
| Re-validation on Upgrade | Start over | Re-run the tool |
Talk to our team about getting your Nessa instance validated in days, not months.