One platform. Every quality process your regulated organization needs.
Kintavo consolidates every quality and compliance function into one configurable, purpose-built eQMS. Not a collection of modules loosely connected — a unified platform where every record, every workflow, and every compliance event is linked to everything else.
Seventeen modules. One connected system.
Every module shares the same data model, the same AI engine, and the same audit trail — so your CAPAs see your deviations, your training sees your documents, and nothing falls between the cracks.
Document Control
The right version. The right hands. Every time.
Deviation Management
Every quality event captured, investigated, and resolved.
Risk Management
Identify risks before they become audit findings.
Equipment Management
Full lifecycle control from qualification to retirement.
Calibration Tracking
Never miss a calibration. Never question your data.
QC Analysis
Statistical control with alerts before limits are breached.
Training Management
Training records that stay current — automatically.
Audit Management
Inspection-ready before the auditor walks in.
Supplier Quality
Qualify, monitor, and audit vendors in one place.
CAPA Management
Root cause found. Corrective action closed. Verified.
Preventive Maintenance
Automated schedules. Zero missed maintenance windows.
AI Smart Assist™
Semantic search and gap detection across every record.
360° Compliance Map™
See how every record connects to everything else.
Audit Intelligence™
Surface compliance gaps before inspectors find them.
Configurable Dashboard
Your compliance picture. Real-time. All in one view.
Workflow Builder
Your team configures processes. No IT required.
Change Control
Every change documented, assessed, and approved.
Specialty Suites
Cell Therapy Suite
The only mid-market eQMS with a dedicated cell therapy operations module. End-to-end patient journey management for CAR-T, TIL, HSC, and experimental therapy programs — from scheduling through infusion and long-term follow-up. Visual storage mapping, automated CIBMTR reporting, configurable processing protocols.
EHS Management
Environmental health and safety management integrated with the full quality system — incident tracking, safety audit management, and regulatory reporting without a separate vendor.
Whatever framework governs your work, Kintavo was built for it.
Every major regulatory framework your organization operates under — covered from day one, not configured after the fact. Filter by category to see what's in scope.
21 CFR
SupportedFDA's core regulations governing drugs, devices, biologics, and electronic records — the backbone of US life-sciences compliance.
Parts covered
ISO Standards
SupportedInternational standards for quality management, medical devices, laboratory competence, and information security.
Standards covered
GxP
SupportedGood Practice quality guidelines spanning manufacturing, laboratory, clinical, distribution, and pharmacovigilance domains.
Practices covered
AABB Standards
SupportedStandards governing transfusion medicine, cellular therapies, and biotherapies — including donor management and patient blood management.
Programs covered
CAP Accreditation
SupportedCollege of American Pathologists laboratory accreditation — the gold standard for clinical and anatomic pathology programs.
Checklists covered
CLIA
SupportedClinical Laboratory Improvement Amendments — federal regulatory standards governing all clinical laboratory testing in the United States.
Complexity levels
SOC 2
SupportedAICPA Trust Services Criteria for security, availability, processing integrity, confidentiality, and privacy of customer data.
Trust criteria
HIPAA
SupportedHealth Insurance Portability and Accountability Act — privacy, security, and breach notification rules for protected health information.
Rules covered
EU Annex 11
SupportedEuropean GMP requirements for computerized systems used in regulated activities — the EU counterpart to 21 CFR Part 11.
Adjacent standards
ALCOA+
SupportedData integrity principles enforced by every kind of audit log Kintavo writes — the operating contract for trustworthy regulated data.
Principles
ICH Guidelines
SupportedInternational Council for Harmonisation guidelines — the global baseline for pharmaceutical quality, safety, and efficacy.
Quality guidelines
Tissue & Cell Therapy
SupportedSpecialty accreditation programs for tissue banks, transplant centers, and cellular therapy programs across North America and Europe.
Programs covered
50+ individual standards mapped across these frameworks. Kintavo customers undergo audits against any combination — without re-tooling, re-validating, or starting over.
Request a DemoWhat Kintavo Replaces
Spreadsheet CAPA tracking → Automated workflows with root cause linkage
Paper document control → Version-controlled e-signature approval with audit trails
Calendar-based PM scheduling → Automated maintenance alerts and lifecycle management
Manual audit binders → One-click audit trail retrieval, everything organized
Disconnected training records → Version-linked acknowledgments with competency tracking
Email approval chains → Automated routing with enforced sign-off and escalations
Whiteboard storage tracking → Visual rack/box/position mapping with temperature alerts
Manual CIBMTR reporting → Automated regulatory form generation
Ready to see the full platform working for your organization?
Book a personalized demo. We'll show you Kintavo configured for your regulatory environment and your specific workflows — not a generic product tour.
FAQ Questions & Answers
Q: How many modules does Kintavo include?
A: Kintavo includes 19 modules across three categories: Core Quality (Document Control, Training, CAPA, Deviation, Audit, Change Control, Risk, Supplier Quality), Operations (Equipment, Calibration, Preventive Maintenance, QC Analysis), and Platform Intelligence (AI Smart Assist™, Workflow Builder, Audit Intelligence™, 360° Compliance Map™, Configurable Dashboard). The Cell Therapy Suite and EHS Management are specialty modules.
Q: Can quality teams configure workflows without IT involvement?
A: Yes. Kintavo's visual Workflow Builder lets quality teams configure approval routing, escalation rules, branching logic, and deadline enforcement themselves — no IT tickets, no vendor change requests. When regulations change, your team reconfigures in hours.
Q: Is the full platform available from day one?
A: Yes. Kintavo is deployed in phases to ensure your team is fully trained on each module before the next goes live — but the full platform is available to your organization from the start of implementation. There are no locked tiers or feature gates within a plan.
Q: Does Kintavo replace our existing LIMS or ERP?
A: Kintavo is a quality management system, not a LIMS or ERP. It integrates with your existing LIMS, ERP, and BECS platforms via API — adding quality and compliance infrastructure without replacing operational systems your team depends on.