High Percentage of Medical Device interface performance Issues
| High Percentage of Medical Device interface performance Issues (kri) |
|
| Type of indicator |
Performance |
| Risk Category |
Data collection |
| Golden KRI |
No |
| Therapeutic Area |
Medical Devices |
| IF Risk-Event |
The interface between the Medical Device and any other system does not work |
| DUE TO Risk Causes |
Insufficient testing of the interface or other cause |
| THEN Risk Impact MAY RESULT |
Out of sync data. |
| Risk Indicator |
High Percentage of Medical Device interface performance Issues |
| Metric |
Percent of the interface malfunction. |
| Unit |
% |
| What level should be measured |
Study, Country, Site |
| Comments |
|
| Purpose |
Optimize the accuracy and reliability of information, ensuring high-quality diagnoses and effective Subject management. |
| Description |
Monitors the occurrence of issues in the data synchronizations. |
| Formula |
Divide a number of synchronizations with min 1 error by total number of synchronizations |
| Suggested Thresholds - High |
≥5 % |
| Suggested Thresholds - Medium |
≥3 % |
| Associated Metric 1 |
Number of synchronizations |
| Associated Metric 2 |
Number of synchronizations with min 1 error |
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