Quality Issue Traceability and Defect Analysis for Medical Device Assembly and Clean Production: Deployment and Upgrade

Data sources for this category include design history files, device and material batch records, MES systems, clean environment monitoring equipment

What data for this category includes

Data sources for this category include design history files, device and material batch records, MES systems, clean environment monitoring equipment, sterilization equipment, inspection and calibration systems. Daily documentation covers production process specifications, batch production records, clean zone records, sterilization batch records, inspection reports, software version records, adverse event and traceability materials. Data is updated once per batch or per finished product unit. Clean environment monitoring data is updated on a fixed schedule. Fields include unique device identification (UDI), batch number, sterilization parameters, clean zone differential pressure, software version number, and other fields aligned with matching measurement standards based on field type.

Constraints for deployment and upgrade

FastGPT v4.17.0 deployment configuration must adapt to this category’s special data requirements. This category’s data involves controlled production documents and patient safety-related traceability information. Deployment must secure data transmission and storage. It requires integration with multiple industrial equipment and systems, with cross-data source synchronization needs. Frequently updated batch and environment monitoring data needs reasonable cache and connection pool parameters configured during deployment. This avoids data delay or loss. Medical device-specific fields such as UDI and sterilization parameters need precise document parsing matching rules configured during deployment. The upgrade process must preserve original traceability data without loss, and comply with production compliance requirements.

How to set configurations

Configuration ItemRecommended SettingRationale
MONGODB_URImongodb://[username]:[password]@[intranet IP]:27017/fastgpt?authSource=adminStores bulk medical device batch data and traceability records; intranet deployment protects sensitive data security
REDIS_URLredis://:[password]@[intranet IP]:6379/0Caches frequently queried clean environment monitoring data to reduce system access latency
FE_DOMAINhttp://[shop floor LAN IP]:3000 or configure a secondary directory pathAdapts to production shop floor LAN access scenarios; prevents inaccessibility caused by changes to container internal IP addresses
FILE_TOKEN_KEYA 32-bit or longer randomly generated string for the production environmentProtects access permissions for uploaded sensitive documents including sterilization batch records and inspection reports
DB_MAX_LINK80–120 connectionsAdapts to scenarios where multiple batch data queries occur simultaneously; prevents database connection exhaustion
ROOT_KEYGenerate only during initial deployment; disable or delete after deployment is completePrevents unauthorized background configuration modifications, and complies with controlled management requirements for medical device production

Three typical mistakes

  • Symptom: A connection timeout or unable to resolve the specified address prompt appears when accessing FastGPT. Cause: FE_DOMAIN is not configured to the shop floor LAN IP, and the container internal IP is still used as the access entry.
  • Symptom: Key fields including UDI and sterilization temperature are missing from the parsing result after uploading a sterilization batch record. Cause: Field extraction rules are not configured for medical device-specific documents, and only a general parsing template is used.
  • Symptom: Historical traceability data cannot be queried after an upgrade. Cause: Batch and traceability data associated with MONGODB_URI was not backed up before the upgrade, resulting in data loss during the upgrade process.

How to verify correct configuration

  • Access the configured FE_DOMAIN address, verify that the system login page opens normally, with no connection errors or 404 status codes.
  • Upload an archived sterilization batch record document, verify that preset fields including batch number and sterilization parameters are extracted correctly after parsing.
  • Check system logs, confirm that the REDIS_URL connection status is normal, with no cache write failure errors.
  • Use the ROOT_KEY to attempt accessing the background configuration page, verify that unauthorized access is blocked by the system, and the configuration interface cannot be entered.

The values provided here are common starting points, and should be measured against the reader's own samples.