Kualitee for Healthcare
Test management built for teams shipping software in HIPAA-regulated and FDA-governed environments.
Kualitee gives your team a complete audit trail, before the auditor asks for one.
Dev & CI/CD Tools
Behind the Platform
Reporting by Default
Why Healthcare QA Teams Choose Kualitee
Healthcare software testing requires more than good coverage. It requires documented, traceable, regulation-aligned proof of coverage. Kualitee is built for both.
HIPAA & FDA Traceability Built In
Map every test case to the HIPAA control, FDA 21 CFR Part 11 requirement, or IEC 62304 clause it covers. When an auditor or regulator asks for evidence, you export a complete traceability matrix in minutes.
Release Confidence for Patient-Facing Software
Kualitee tracks pass rates, defect density, and test coverage per release. QA managers and dev leads see the same data before every deployment. No more release decisions made on incomplete information.
Structured Workflows for Regulated Releases
Define approval gates that mirror your regulatory sign-off process. No test cycle can be marked complete without the required coverage and review on record. Your pipeline stays audit-ready end to end.
AI-Assisted Testing with Hootie
Hootie helps your team generate test cases from requirements, identify coverage gaps, and flag risk areas before a release. Faster coverage across complex clinical and EHR workflows without cutting corners.
From First Test to Regulation-Ready Release
Kualitee fits into your existing healthcare QA workflow without disrupting it. Here is how teams use it.
Map Requirements to Regulatory Frameworks
Tag requirements against HIPAA controls, FDA 21 CFR Part 11 clauses, or IEC 62304 software lifecycle requirements. Every test case written from this point carries a regulatory context.
Build and Organize Test Suites
Write test cases manually or use Hootie AI to generate a baseline. Group into suites by module, risk classification, or compliance domain, EHR workflows, clinical decision logic, data encryption, access controls.
Run Cycles with Full Traceability
Execute within Kualitee or sync results from automation tools. Every result is logged against the test case, the build version, and the tester. Nothing is undocumented.
Track Defects Against Regulatory Exposure
Every defect links to the test case it failed and the requirement it was covering. Dev leads see what broke, what regulation it touches, and what the patient safety or compliance risk is.
Generate Reports and Obtain Sign-Off
Before any release, generate a compliance coverage report. Document what was tested, what passed, and what was deferred with formal risk acceptance. Sign-off is timestamped and on record.
Result: Every release ships with a complete, timestamped, regulation-aligned audit trail.
Frequently Asked Questions
Your Next Audit Should Be the Easy Part
Every test your team runs becomes part of a permanent, regulation-ready record. Start today.