Data Overview for This Category
Data sources for this category include design history files, device and material batch ledgers, manufacturing execution systems (MES), clean environment monitoring equipment, sterilization equipment, and inspection and calibration systems. Daily documentation covers production process specifications, batch production records, clean zone operation records, sterilization batch records, inspection reports, software version records, adverse event and traceability materials. Data updates are performed per product batch or per individual device. Environmental data is updated in line with clean environment monitoring plans. Data fields include unique device identification, material batch numbers, sterilization parameters, clean zone temperature and humidity, software version numbers, and additional relevant fields. Unit formats adapt to the corresponding document type.
Constraints on Deployment and Upgrade
Multi-source, scattered data sources require pre-configuration of multi-system integration during the deployment phase. This prevents data synchronization gaps. The high-frequency update rhythm requires configuring appropriate scheduled synchronization task parameters during deployment. This ensures timely ingestion of per-batch or real-time data. Diverse document structures and non-uniform fields require reserving flexible parsing rule adjustment entries during the upgrade phase. This adapts to field extraction needs for different documents. Core data related to patient safety and product traceability requires configuring storage and access permissions that meet compliance requirements during deployment. This prevents unauthorized tampering of data.
Configuration Settings
The following configurations are adapted for FastGPT v4.17.0.
| Configuration Item | Recommended Setting | Rationale |
|---|---|---|
MONGODB_URI | Dedicated instance address with access whitelist; connection pool size set to 20–30 | This category’s data is updated at high frequency per batch. Stable concurrent connections are required |
REDIS_URL | Memory limit set to 1000 MB; key expiration time set to 3600 seconds | Real-time clean environment monitoring data and user permission information must be cached to avoid repeated queries |
STORAGE_S3_ENDPOINT | Compliant domestic cloud storage endpoint; version control enabled | Sterilization batch records, traceability materials, and other documents require historical version retention to meet compliance requirements |
DB_MAX_LINK | 15–25 | Adapts to concurrent requests from multi-source data synchronization. Prevents connection pool exhaustion |
FE_DOMAIN | Secondary domain name registered for internal enterprise use | Ensures security and manageability of internal access |
Three Common Misconfigurations
- Symptom: Dependency errors occur during local deployment packaging. Logs indicate incompatibility with the document parsing module version. Cause: Dependency versions optimized for medical device document parsing are not locked. This creates conflicts with FastGPT core dependencies.
- Symptom: Custom clean zone record parsing rules do not activate after successful packaging and deployment. The interface shows empty extracted fields. Cause: Parsing rule configurations are not pushed to all deployment nodes during the upgrade process. This leads to inconsistent instance configurations.
- Symptom: Request timeouts occur during batch synchronization of sterilization batch records. Status code 504 is returned. Cause: The
DB_MAX_LINKparameter is not adjusted to support multi-source data concurrent requests. This exhausts the database connection pool.
How to Verify Proper Configuration
- Access the management interface associated with
FE_DOMAIN. Review the data connection configuration list. Confirm that the addresses forMONGODB_URIandREDIS_URLmatch the preset values. - A sterilization batch record document may be uploaded to trigger a parsing task. Verify that the parsed result fields cover all preset extraction items.
- Execute the batch data synchronization script. Monitor the system connection count. Confirm that the connection count stays within the range defined by
DB_MAX_LINK. - Review the version control status of the storage bucket. Confirm that the storage service linked to
STORAGE_S3_ENDPOINThas historical version retention enabled.
The values provided here are common starting points. They should be evaluated against local samples.