Kintavo

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Kintavo is a cloud-based, AI-native electronic quality management system (eQMS) purpose-built for regulated healthcare and life sciences. It brings document control, CAPA, deviation management, training, audits, risk, equipment and calibration, supplier quality, and change control into one connected platform — engineered for 21 CFR Part 11, ISO 13485, AABB, GxP, and related frameworks from day one, not configured in after the fact. Seventeen modules share a single data model, AI engine, and immutable audit trail, so CAPAs, deviations, training, and documents stay linked instead of scattered across disconnected tools. Quality teams configure their own approval routing, escalation rules, and branching workflows through a visual builder — no IT tickets, no vendor change requests — while AI Smart Assist, the 360° Compliance Map, and Audit Intelligence surface compliance gaps before an inspector does. Kintavo serves blood banks, clinical and reference laboratories, medical device manufacturers, pharma and biotech, CDMOs, CROs, health systems, and cell and gene therapy programs — and is the only mid-market eQMS with a dedicated Cell Therapy Suite for CAR-T, TIL, and HSC programs. Implementation runs in weeks rather than months, with phased deployment, quality-team training, and IQ/OQ/PQ validation documentation included in every plan and pricing published up front. Quality teams of all types, from regional blood centers to NCI-designated cancer programs, run their compliance infrastructure on Kintavo.