AI-NATIVE eQMS · BUILT FOR LIFE SCIENCES
Quality that works with your team. Not against them.
Kintavo is the AI-native eQMS for regulated healthcare and life sciences. Replace the binders, the email chains, and the manual decisions — with a system that thinks alongside your team.
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.
Trusted by Regulated Organizations
We built Kintavo because quality teams deserved better.
We know what it's like to manage compliance with a patchwork system. The endless prep. The scramble before an inspection. The hours lost to administrative work that could have been spent on something that actually moves the needle.
We built Kintavo for the quality leader who deserves a system that has their back. Not another tool to manage, but a platform that runs the compliance infrastructure so your team can focus on the improvement work that actually matters.
Three steps to a quality system that works for you.
1. Book Your Personalized Demo
We'll show you Kintavo configured for your regulatory environment and your workflows — not a generic slide deck. Bring your real pain points. We'll show you exactly how it solves them.
2. Complete a QMS Health Assessment
We evaluate your current quality system, identify your highest-risk gaps, and give you a written assessment. It's useful whether you move forward with Kintavo or not.
3. Go Live in Weeks, Not Months
Phased implementation with validation documentation included. Document Control and Training live in weeks 1-2. CAPA and deviations in weeks 3-4. Full go-live with validation sign-off in weeks 7-8. Your team is trained and confident before you ever go live.
Built for the regulated edges of healthcare and life sciences.
Same Kintavo platform, configured for the rules and rhythms of your domain. Browse by category — clinical operations, development & manufacturing, or specialized therapies.
Clinical operations & care delivery
Healthcare & Health Systems
Quality, accreditation, and incident programs that span hospitals, IDNs, and ambulatory networks — without the overhead.
Explore HealthcareClinical Laboratories
CLIA, CAP, and ISO 15189 quality programs purpose-built for clinical, anatomic path, and molecular laboratories.
Explore Clinical LabsBlood Banks & Transfusion
AABB, FDA, and ISBT-aligned workflows for blood banks, transfusion services, and apheresis programs.
Explore Blood BanksDevelopment, manufacturing & commercialization
Life Sciences
An umbrella platform for research, translational, and clinical-stage life-sciences organizations operating under GxP.
Explore Life SciencesPharma & Biotech
GMP-compliant quality for branded, generic, specialty pharma, and biologics — built for FDA, EMA, and PMDA scrutiny.
Explore Pharma & BiotechMedical Devices
ISO 13485 and 21 CFR Part 820 out of the box — with design controls, DHF management, and post-market surveillance.
Explore Medical DevicesCDMOs
Multi-client, multi-product quality systems for contract development & manufacturing — with sponsor-isolated data and reporting.
Explore CDMOsCROs
GCP-aligned quality and document control across multi-site, multi-sponsor clinical research operations.
Explore CROsSpecialized therapies & tissue programs
Cell & Gene Therapy
Patient-specific lots, chain-of-identity, and the regulatory rigor that comes with autologous and allogeneic therapies.
Explore Cell & GeneOrgan & Tissue
Tissue banks, transplant programs, and biorepository compliance — built for the chain of custody these programs demand.
Explore Organ & TissueDon't see your industry? Kintavo is configurable to any GxP-regulated environment. Talk to us about your specific compliance scope.
Talk to our teamWhatever 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 Demo99.2% Audit Success Rate
75% Reduction in Compliant Task Time
Audit Prep in Hours
Trusted by the teams that can't afford to fail an audit.
Blood centers, cancer programs, health systems, and reference labs run their compliance infrastructure on Kintavo. Here's what they say about it.
"After using the Kintavo platform, MD Anderson users reported that Kintavo made a great impact on their daily operations. Employees praised Kintavo's intuitive design, flexibility, simplicity, and the support received from the team."
MD Anderson Cancer Center
Houston, TX
"It was a no-brainer for us to implement Kintavo."
National Blood Collaborative
Blood solutions · Trusted shared
"Kintavo is the perfect solution for a regional blood center because it grows with you. We can automate our daily quality control processes, improve efficiency, and reduce costs. Hoxworth expects to save 4× our investment in unnecessary spending in our first year on the platform."
Hoxworth Blood Center
University of Cincinnati
"Kintavo has been very responsive to our needs, enabling us to develop and customize reagent and blood QC apps quickly, ultimately supporting top-notch quality care for our patients."
Avera Health
Sioux Falls, SD
"The most immense value of Kintavo is that after implementation, you're able to do all of these additional tasks that you didn't have time for before."
SCL Health
Broomfield, CO
From regional blood centers to NCI-designated cancer programs, Kintavo customers share one thing: they've stopped worrying about audits.
Request a DemoWhat changes when you have a quality system that actually works?
The audit notice arrives. Your team doesn't panic. Everything is organized, everything is retrievable, and every gap you know about is already in a CAPA with a closure date.
The inspector walks in. You walk them through it with confidence — not dread.
You close your laptop on a Friday and you're not running through the mental checklist of things that might slip over the weekend. The system is running. Nothing is falling through.
That's not a product pitch. That's what your job is supposed to feel like.
The alternative? Staying the same.
Every year the patchwork system stays in place, the compliance risk grows. Audit prep stays a fire drill. Talented quality professionals burn out managing a system that was never designed for the work they're doing. And somewhere in the back of your mind, the quiet concern never fully goes away: something important is going to slip through.
That concern is telling you something. It's worth listening to.
FAQ Questions & Answers
Q: What is Kintavo?
A: Kintavo is a cloud-based eQMS purpose-built for regulated healthcare and life sciences — document control, CAPA, training, equipment management, deviation tracking, and audit readiness in one configurable platform. Built for 21 CFR Part 11, ISO 13485, AABB, GxP, and related frameworks from day one.
Q: How long does implementation take?
A: Kintavo goes live in 6-8 weeks. Document Control and Training in weeks 1-2. CAPA and Deviation Tracking in weeks 3-4. Full go-live with validation sign-off in weeks 7-8.
Q: Is Kintavo 21 CFR Part 11 compliant?
A: Yes — built in from day one, not adapted from generic software. Electronic signatures, immutable audit trails, role-based access control, and validation documentation are included in every plan.
Q: Who is Kintavo built for?
A: Quality leaders in regulated healthcare and life sciences organizations — blood banks, medical device manufacturers, clinical laboratories, pharma and biotech, cell therapy programs, CDMOs, and health systems. 50+ employees.
Q: How does Kintavo compare to MasterControl or Veeva?
A: Same regulatory rigor. Quality teams configure their own workflows using visual process builders — no IT dependency. Implementation takes weeks, not months. Pricing is published and includes implementation and validation documentation.
Q: Can our quality team configure workflows without IT? A: Yes. Kintavo's visual Workflow Builder lets your quality team configure approval routing, escalation rules, and branching logic themselves. No IT tickets. No vendor change requests. When regulations change, you reconfigure in hours.
Q: What regulatory frameworks does Kintavo support? A: 21 CFR Parts 11, 210/211, 820/QMSR, and 606. ISO 13485, ISO 15189, ISO 17025. GxP — GMP, GLP, GCP. AABB Standards. CAP. CLIA. HIPAA. SOC 2. EU Annex 11. ALCOA+.
Q: Is implementation included in the price? A: Yes. Phased deployment, quality team training, and IQ/OQ/PQ validation documentation are included in every plan. We do not charge separately for getting you live.
Q: Does Kintavo include equipment management and calibration? A: Yes. Equipment lifecycle management, calibration tracking with drift detection, preventive maintenance scheduling, and QC analysis are all included in the Full Platform plan — not add-ons.
Q: Is there a Cell Therapy module? A: Yes. Kintavo is the only mid-market eQMS with a dedicated Cell Therapy Suite — end-to-end patient journey management for CAR-T, TIL, and HSC programs with visual storage management and automated CIBMTR reporting.
Q: Does Kintavo integrate with our LIMS, ERP, or BECS? A: Yes. Kintavo integrates with existing LIMS, ERP, and BECS platforms via API — adding quality management infrastructure without replacing the operational systems your team depends on.
Q: Is Kintavo HIPAA compliant? A: Yes. Role-based access controls, audit trails for all PHI access, encryption at rest and in transit, and Business Associate Agreement execution for covered entities.