The Case Data line type records significant case data values used to capture decisions and decision-related information for an item. Typical examples include quality or disposition decisions such as Pass/Fail, Rework, Scrap, or Concession, together with supporting information that explains the decision.

Case data is commonly used for two distinct purposes:

1. Transactional information, where the value is used only to support workflow execution and does not need to be retained in the eDHR.
2. Decision and disposition records, where the value represents an important manufacturing or quality decision and must become part of the permanent device history record. Examples include:

• • Pass or fail decisions.
  • Rework, scrap, or concession decisions.
  • Supporting rationale or additional information associated with a decision.

The Case Data line type addresses the second scenario by allowing designated case data values to be recorded and versioned within the eCHR.

Configuration

A Case Data line is configured within an eCHR profile to identify which case data fields should be tracked. Only case data explicitly configured in the profile are eligible for inclusion in the eDHR. Any other case data values are ignored for eDHR record creation.

This selective approach enables organisations to capture only those data elements that are considered significant from a manufacturing, quality, or regulatory perspective.

Trigger

The Case Data Line Type is triggered when the configured case data value is populated for the first time for the item.

The record is revised when the value of the configured case data changes after the initial entry. Any subsequent update results in an up-revision of the existing eCHR record.

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