What data for this category looks like
Core data for this category comes from design history files, device and material batch records, MES systems, clean environment monitoring equipment, sterilization equipment, and inspection and calibration systems. Daily documents include production process specifications, batch production records, clean zone environment records, sterilization batch records, inspection reports, software version records, and adverse event traceability materials. Data updates are performed per product batch or per device. Clean zone environment data is updated regularly per monitoring plans. Data fields include batch number, unique device identifier, sterilization parameters, clean zone temperature and humidity, software version number, and more. Some fields must comply with medical device traceability requirements.
Constraints imposed on HTTP interfaces and external systems by these characteristics
Data for this category is updated per batch and has strict traceability and permission requirements. These impose multiple constraints on HTTP interface configuration. Interfaces must support precise queries using parameters such as batch number and clean zone ID. This ensures return of process specification and standard data for the corresponding production batch. Interfaces must use the Authorization parameter for strict permission control. This prevents unauthorized access to sensitive medical device production data. Because data updates are frequent and include real-time device data, interfaces must support incremental synchronization and reasonable timeout settings. This avoids request failures caused by overly long data read times. Returned data must also filter non-controlled fields. This ensures only compliant traceability and process information is transmitted.
How to set up the configuration
The following configurations are compatible with FastGPT v4.17.0.
| Configuration Item | Recommended Setting | Rationale |
|---|---|---|
Authorization parameter | Bearer ${Enterprise-specific API key} | Medical device production data requires strict permission control to prevent unauthorized access |
Request variables parameter template | {"batchNo": "", "cleanAreaId": "", "deviceType": ""} | Precisely match process specifications and technical standards by batch, clean zone, and device type |
responseData field filtering | Return only controlled fields: batchNo, uniqueDeviceId, sterilizeParam | Avoid returning sensitive adverse event or unauthorized traceability data |
| Request timeout | 30 seconds | Requires reading real-time data from sterilization equipment and clean environment monitoring systems, which takes longer |
| Historical conversation retention limit | First 2 historical records | Process Q&A must focus on current batch requirements, avoiding interference from redundant information |
| Number of data items per request | 50 items/request | Balances data transmission efficiency and interface load |
Three common errors
- Symptom: Interface returns empty results or missing fields. Cause: Core
variablesparameters such as batchNo and cleanAreaId are not specified per category requirements. This prevents matching process specification data for the corresponding batch. - Symptom: Non-current batch process content appears in conversation history. Cause: The number of retained historical conversations is not limited. Old batch process data is included in the current Q&A flow, which does not meet the focus requirements of process Q&A.
- Symptom: Interface returns 403 status code or access failure prompt. Cause: The required
Authorizationparameter is not configured correctly, or the key permissions do not cover access to medical device production data.
How to confirm the configuration is complete
- Call the configured HTTP interface, pass a known valid production batch number, and verify that the returned fields include the expected process specification and technical standard content.
- Send two consecutive Q&A requests, and verify that the conversation history only retains the specified number of records, with no redundant content from non-current batches.
- Pass an invalid batch number or unauthorized key, and verify that the interface returns the correct error status code and prompt information.
- Trigger the knowledge base synchronization interface, and verify that the process data for the corresponding batch has been successfully updated to the knowledge base.
The values provided here are common starting points, and should be evaluated against the reader's own samples.