This document is written based on the workflow functionality of FastGPT v4.17.0.
What This Category of Data Looks Like
The data for inspection and process record review in finished pharmaceutical dosage form manufacturing comes from approved formulation processes, material batches, MES electronic batch records, equipment and environmental monitoring data, LIMS inspection systems, and quality management systems. Daily documents include master production files, batch production records, batch packaging records, cleaning records, inspection records, deviation/CAPA/change documents, and batch release review forms. Data updates are centered on each production batch, with synchronized updates for key process steps and monitoring plan nodes. Fields include batch number, material lot number, process parameters, inspection results, and deviation descriptions. All fields must comply with GMP requirements for format and integrity standards.
What Constraints Do These Characteristics Impose on Workflow Orchestration
The need for multi-source data access requires workflows to support parallel pulling of data from different systems to avoid excessive load on a single node. The batch-based update feature requires workflows to bind batch-specific trigger conditions, ensuring that review processes start only after production for the corresponding batch is complete. Under GMP compliance requirements, workflows must validate the integrity and format of each field to prevent non-compliant data from entering the review stage. Time-consuming review and aggregation steps need to be split into parallel nodes, breaking down item-by-item review, deviation aggregation, and release judgment into independent tasks to improve execution efficiency. At the same time, all node operations must support audit trails to meet regulatory requirements for traceability.
How to Configure
| Configuration Item | Recommended Approach | Rationale |
|---|---|---|
| Trigger Node Configuration | Trigger via batch number update in variables, or bind a signal node for batch production completion | Data updates follow each production batch cycle, so review processes must be tied to specific batches for execution |
| Multi-source Data Access Polling Interval | 600 seconds | Match the monitoring interval of key production steps, avoid excessive data pulling that occupies system resources |
| Field Validation Rules | Validate that batch number, material lot number, and process parameter fields in variables are not empty and have compliant formats | Meet GMP requirements for data integrity, prevent non-compliant data from entering the review stage |
| Failure Retry Strategy | 3 retries, with 120 seconds between each retry | Address temporary fluctuations in production data or short system outages, avoid process termination due to single abnormal events |
| Parallel Node Quantity Limit | No more than 5 parallel nodes | Avoid excessive data pulling that causes high system load, comply with resource configurations in production environments |
| Node Mapping Configuration | Use nodeId to bind field transfer relationships between upstream and downstream nodes | Ensure precise field matching across multiple documents, comply with batch record association requirements |
Three Common Errors
- Phenomenon: Workflow loop nodes have no termination condition, resulting in duplicate generation of review records for the same batch. Cause: The batch number in
variablesis not bound as the loop termination identifier, and the loop logic is not tied to a specific batch. - Phenomenon: After restoring a project backup, the knowledge base and variable configurations associated with the workflow are lost. Cause: Only the project file was restored, and the
variablesvariable set was not backed up and restored, so configuration data relied on by nodes cannot be restored. - Phenomenon: Mixing workflow connection points on the right side and bottom, resulting in incorrect execution order of review processes. Cause: The execution logic of connection points is not clearly defined: bottom connection points are for serial execution branches, and right connection points are for parallel execution branches. Mixing them disrupts the business sequence of review, aggregation, and release.
How to Verify Correct Configuration
- Trigger Test: Submit simulated batch data, check whether the workflow automatically starts execution after the corresponding batch signal is triggered.
- Field Validation Test: Input field values that do not comply with GMP formats, check whether nodes trigger validation errors and block the workflow.
- Failure Retry Test: Simulate a temporary outage of the data source, check whether the workflow executes retries as configured and resumes execution after recovery.
- Node Connection Test: Connect upstream and downstream nodes in sequence according to the production review business process, confirm that parallel branches and serial order meet expectations.
The values provided are common starting points and should be measured against the reader's own samples.