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 QMS → output.json → QA approval / audit trail
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| CalibrationScheduleChecker | Calibration Schedule Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| CalibrationStatusChecker | Calibration Status Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| CAPAEffectivenessChecker | CAPAEffectiveness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ChangeControlImpactChecker | Change Control Impact Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ComplaintTrendChecker | Complaint Trend Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignInputCompletenessChecker | Design Input Completeness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignOutputConsistencyChecker | Design Output Consistency Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignReviewChecklistChecker | Design Review Checklist Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignValidationCoverageChecker | Design Validation Coverage Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignVerificationCoverageChecker | Design Verification Coverage Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DHFCompletenessChecker | DHFCompleteness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DHRCompletenessChecker | DHRCompleteness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DMRCompletenessChecker | DMRCompleteness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| IncomingInspectionSamplingChecker | Incoming Inspection Sampling Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| InternalAuditFindingTrendChecker | Internal Audit Finding Trend Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| MedicalDeviceQMSSuite_LabelingConsistencyChecker | Medical Device QMSSuite Labeling Consistency Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| NonconformityTrendChecker | Nonconformity Trend Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SupplierEvaluationChecker | Supplier Evaluation Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| TraceabilityMatrixChecker | Traceability Matrix Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| TrainingMatrixComplianceChecker | Training Matrix Compliance Checker | Medical Devices / MedicalDeviceQMS 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.