Почему выбирают FUZKK
✓ Меньше Excel-рисков
Детерминированные расчёты и проверки правил вместо неконтролируемых таблиц.
🔍 Готовность к аудиту
Пакет содержит автономные CSV→JSON QC-утилиты FUZKK. Каждая утилита имеет встроенное самоописание, пример input.csv, demo-evaluation и LabWare-compatible JSON output.
⏱ Время лаборатории
Более быстрая проверка данных, ревью партии и структурированный JSON-результат для последующих систем.
🚀 Интеграция
Подходит для CSV, LIMS/ELN/MES и валидируемых лабораторных процессов.
Схема интеграции
Instrument / LIMS / ELN / MES → input.csv → Medical Device Software → output.json → QA approval / audit trail
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| CodeReviewCoverageChecker | Code Review Coverage Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ConfigurationBaselineChecker | Configuration Baseline Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DefectTrendChecker | Defect Trend Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| IntegrationTestCoverageChecker | Integration Test Coverage Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RegressionTestCompletenessChecker | Regression Test Completeness Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ReleaseReadinessChecker | Release Readiness Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RequirementTraceabilityChecker | Requirement Traceability Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskRequirementTraceabilityChecker | Risk Requirement Traceability Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareArchitectureRiskChecker | Software Architecture Risk Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareBuildReproducibilityChecker | Software Build Reproducibility Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareMaintenanceImpactChecker | Software Maintenance Impact Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareProblemResolutionChecker | Software Problem Resolution Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareSafetyClassChecker | Software Safety Class Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SOUPInventoryChecker | SOUPInventory Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SOUPVersionChecker | SOUPVersion Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| StaticAnalysisSummaryChecker | Static Analysis Summary Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SystemTestCoverageChecker | System Test Coverage Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| UnitTestCoverageChecker | Unit Test Coverage Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 |
Лицензирование и поддержка
Поставка as-is на юридическое лицо без права перепродажи. Валидация, CSV/URS/FS review и внедрение в LIMS выполняются на стороне заказчика или отдельным проектом.