The AI-native eQMS for regulated healthcare and life sciences.
Kintavo runs the compliance infrastructure — documents, training, CAPAs, deviations, equipment, audits — as one connected system on one data model, one AI engine, and one audit trail.
What it is
Nineteen connected modules spanning core quality (document control, deviation, risk), operations (equipment, calibration, QC analysis, training, audits, suppliers, CAPA, maintenance, inventory, contracts), and intelligence (AI Smart Assist™, 360° Compliance Map™, Audit Intelligence™, dashboards, workflow builder, change control).
Who it serves
Blood centers and transfusion services, clinical laboratories, health systems, medical device and pharma manufacturers, CDMOs/CROs, and cell & gene therapy programs — with AABB, CLIA/CAP, ISO 13485/15189, 21 CFR Part 11 and GMP workflows native rather than configured from scratch.
Why teams switch
- Weeks, not quarters: guided implementation in 8–12 weeks with IQ/OQ/PQ validation documentation included with every plan and release.
- No-code control: quality teams configure workflows, routing, and escalation themselves — changes land in hours, not vendor tickets.
- Inspection-ready by default: continuous readiness scanning and immutable, append-only audit trails aligned to ALCOA+.
- Security: SOC 2 Type II report available; HIPAA BAAs available; encryption at rest and in transit.
See it running
Book a 30-minute personalized demo at kintavo.com/demo — configured for your regulatory environment, on your workflows.