Calculate Your ROI

Annual cost of your QA/compliance staff based on 15 employees at an average fully loaded cost of $110K/year.

This includes salary, benefits, training, and overhead for personnel dedicated to data integrity, audit management, and regulatory compliance activities.

External consultant fees for IQ/OQ/PQ protocol development, execution, and system validation. Industry average is $200-400/hour for qualified validation specialists.

Nessa eliminates 70% of this cost by providing pre-built validation protocols, an automated test runner (83 test cases), and 8 ready-to-use SOPs.

Calculated as $30K per system (potential FDA 483 observation remediation) plus $15K per employee above 10 (manual error probability).

54% of FDA warning letters cite data integrity as the primary violation. Average remediation cost: $4.2M. Nessa reduces this risk by 85% through automated audit trails, cryptographic verification, and real-time ALCOA+ scoring.

Professional tier: 100 users, all compliance modules (ALCOA+, audit trails, e-signatures, risk scoring), validation package included, priority support.

Includes: FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ISO 27001, HIPAA, and GDPR compliance coverage.

23-document validation package: 82 User Requirements, 55 Functional Specs, 83 OQ test cases, 89 FMEA risk entries, 8 SOPs, traceability matrix (100% coverage).

Includes automated validation runner — executes 44 tests in under a minute with cryptographically signed evidence report. Your QA team reviews and signs. Done in 1-2 weeks instead of 6-12 months.

Headcount reduction: Nessa automates ~40% of compliance work. 6 FTE equivalent saved at $110K each = $660K.

Consultant reduction: 70% eliminated by built-in validation = $140K saved.

Risk reduction: 85% lower exposure through automated integrity controls = $76.5K saved.