Define the interface
Document the source and destination systems, data owner, data elements, units, identifiers, mapping, transformation rules, frequency or trigger, acknowledgement, error handling, retry, reconciliation, security, audit trail, monitoring, and accountable support roles. Clarify which system is authoritative for each field and status.
Minimum test scenarios
| Scenario | Evidence to retain |
|---|---|
| Normal transfer | Source value, transmitted payload, destination value, status, acknowledgement, and timing |
| Incorrect or invalid data | Rejection or hold behavior, error detail, ownership, and no unintended posting |
| Missing or partial data | Required-field control, message state, exception record, and recovery |
| Duplicate or out-of-order data | Idempotency or duplicate control, sequence behavior, and business result |
| Delayed or failed transfer | Alert, queue state, retry, manual action, and reconciliation |
| Mapping or transformation error | Expected conversion, precision, unit, code, status, and boundary behavior |
| Recovery and reconciliation | Complete replay without duplicate effect and accountable exception closure |
Completed fictional LIMS-to-ERP example
The interface sends an approved assay result from the laboratory information management system (LIMS) to enterprise resource planning (ERP). The payload includes result value, unit, material, batch, sample, method, specification status, approval status, and timestamp. Tests challenge valid transfer, an unknown unit, missing batch identifier, duplicate message, delayed acknowledgement, destination outage, retry, partial payload, incorrect material mapping, and daily reconciliation.
The unknown unit initially defaults to percent and posts successfully. This is a validation deviation because a technically successful message has incorrect meaning. The design is changed to hold unrecognized units, create an accountable exception, and prevent material-status update. Targeted retest and end-to-end reconciliation pass before release.
Regulatory and procedural context
Primary sources. 21 CFR Part 11 ↗ is relevant where the interface creates, modifies, maintains, retrieves, or transmits records in scope. EU GMP Annex 11 ↗ addresses data exchange, accuracy checks, security, and continuity for applicable GMP systems.
Company procedure. The organization’s approved validation, change-control, supplier-management, information-security, data-integrity, records-retention, and Quality approval procedures determine the required records, roles, and approval route.
CSVtoCSA practitioner interpretation. A successful transport code is not evidence that the correct regulated meaning reached the correct record and controlled process. This is a recommended validation approach, not a statement that every listed activity is a direct regulatory requirement.