What Data Looks Like for This Category
The typical entities in this category are manufacturers of single-use consumables, implantable and interventional devices, diagnostic equipment, and active medical devices. Daily documents include production process specifications, batch production records, clean zone records, sterilization batch records, test reports, software version records, adverse event and traceability materials. Data sources include design history files, device and material batch ledgers, MES systems, clean environment monitoring equipment, sterilization equipment, testing and calibration systems. Update frequency is once per batch or per product unit, or at regular intervals per environmental monitoring plans. Documents contain structured and unstructured fields such as unique device identifiers, batch numbers, sterilization parameters, and cleanliness values.
Constraints Imposed by These Characteristics on Document Parsing and Chunking
Documents in this category have diverse types. They include formatted batch record tables and long-text process specifications. Fields are highly correlated. Key information such as unique identifiers and sterilization parameters must be retained to support traceability. Associated documents for a single batch of products may reach hundreds of pages, leading to long parsing times. The workflow must adapt to frequently updated bulk documents. At the same time, documents must meet strict traceability requirements. Chunking must not split field correlations, as this will affect accurate positioning of subsequent quality issues and root cause analysis.
Configuration Settings
This configuration applies to FastGPT v4.17.0.
| Configuration Item | Recommended Setting | Rationale |
|---|---|---|
PARSE_FILE_TIMEOUT_SECONDS | 600–900 seconds | A single batch sterilization record may exceed 500 pages; locally deployed parsing tools have long processing times, and the default timeout value is insufficient to cover the full parsing workflow |
UPLOAD_FILE_MAX_SIZE | 2000 MB | Combined software version records and assembly logs for a single active medical device may exceed 1 GB; this setting adapts to bulk document upload requirements |
chunkSize | 800–1200 characters | Key fields of batch production records (such as sterilization temperature and batch number) are mostly distributed in single paragraphs; this length can cover a complete set of test data |
customPdfParse | Enabled | Documents in this category often contain structured tables and controlled numbers; custom parsing preserves the correlation between fields, avoiding inability to associate batches and test data during traceability |
chunkSplitter | Split by paragraph + heading | Clean zone records are divided by shift into paragraphs; splitting by headings preserves the correspondence between batches and environmental parameters |
chunkSettingMode | Manual configuration | Adjust chunking parameters for different document types such as sterilization batch records and adverse event reports to meet the accuracy requirements of quality traceability |
Three Common Misconfigurations
- When uploading a sterilization batch record with more than 500 pages, the interface shows parsing timeout or remains in the waiting queue without a response for a long time. The cause is failure to adjust the
PARSE_FILE_TIMEOUT_SECONDSparameter; the default value is insufficient to cover the full parsing process of large files. - An error is triggered when using doc2x to parse hundreds of pages of clean zone records, while documents of tens of pages parse normally. The cause is failure to set
UPLOAD_FILE_MAX_SIZEandPARSE_FILE_TIMEOUT_SECONDS; large files exceed upload limits or experience parsing timeouts. - A large amount of duplicate field content appears after chunking, leading to redundant recall results. The cause is failure to adjust
chunkSizeandchunkSplitter; the chunking logic does not adapt to the field boundaries of structured documents, causing the same set of data to be split into multiple chunks.
How to Verify Proper Configuration
- Upload a single 500-page sterilization batch record PDF, and check whether the parsing status completes within the duration set by
PARSE_FILE_TIMEOUT_SECONDSwith no timeout error prompts. - After adjusting the
chunkSizeparameter, review the parsed chunk results to confirm that a single chunk contains complete sterilization parameters and batch number information. - After enabling
customPdfParse, check whether the parsed document retains structured fields in tables, such as cleanliness values and sterilization time. - Upload multiple documents of different types to confirm that the
UPLOAD_FILE_MAX_SIZElimit is not triggered.
The values provided here are common starting points and should be measured against the reader's own samples.