Defining Trend Charts

Trend Charts allow Veeva LIMS users to view embedded statistical process control charts on a given Spec Execution to:

  • Compare a batch’s results against previous batch results and determine whether it’s in control or out of trend.
  • Analyze stability trending in order to identify regression results that are trending towards an earlier than expected expiration, thus proactively preventing product or process failures and recalls before they become specification failures.

If configured by a Vault Admin, a Design Data Admin can define up to 50 Trend Charts per Batch Release Spec Data.

Supported Chart Types

The following types of control charts are available for definition in Veeva LIMS: X-bar, R Chart, S Chart, I-MR Chart, and Regression.

Creating a Trend Chart Definition

To create a Trend Chart Definition:

  1. Open the Batch Release Spec Data Detail page.
  2. Create a Trend Chart Definition related record.
  3. Select a Chart Type. For Batch Release Spec Data, only Control Charts (X-bar, R Chart, S Chart and I-MR Chart) are valid. If you select an invalid chart type, you will receive an error when attempting to make its Spec Data effective.
  4. Enter a Name.
  5. Enter a Description.
  6. Select a Test Definition and Result Definition. Only Result Definitions that have an Out of Spec criteria are supported.
  7. Fill in the applicable fields for the chart type.
  8. Click Save.

When you create a Trend Chart Definition record, Veeva LIMS automatically creates a Trace ID for the record. The system uses this ID to track Trend Chart Definition versioning across multiple Spec Data.

Defining Regression Charts for Stability Studies

Most trend chart types are only available for Batch Releases, but Design Data Admins can define linear and exponential regression charts for Stability Studies. These charts allow users to compare Stability Study Results with the same Storage Condition and Orientation in order to predict when the Result will be Out of Spec (OOS).

How to Define Regression Charts for Stability Studies

To create a Regression Trend Chart Definition for a Stability Study:

  1. Open the Stability Study Spec Data Detail page for which you want to define a chart.
  2. Create a Trend Chart Definition related record.
  3. Select a Chart Type. For Stability Spec Data, only Regression is valid. If you select an invalid chart type, you will receive an error when attempting to make its Spec Data effective.
  4. Enter a Name.
  5. Enter a Description.
  6. Select a Regression Line Type.
  7. Enter a Prediction Interval.
  8. Select a Criteria. Only Criteria defined using simple mode is supported.
  9. Click Save.

Trend Chart Definition Limitations

Keep the following limitations and requirements in mind when creating Trend Chart Definitions for Batch Releases:

  • You can only create Trend Chart Definitions for Spec Data of type Batch Release. Regression chart definitions, which can also be created for Spec Data of type Stability, are the only exception.
  • For a given Spec Data, you can create a maximum of 50 Chart Definitions.
  • For a given Test Definition, you can create a maximum of five Test Definition Results across Variations that include Chart Definitions.
  • For a given Test Definition Result, you can create a maximum of three Trend Chart Definitions across Variations within the same Spec Data.
  • Trend Chart Definitions may not be of custom object types, and once created, their object types cannot be changed.
  • A Trend Chart Definition’s Result must be numeric.
  • A given Spec Data cannot include duplicate Trend Chart Definitions. Trend Chart Definitions are considered duplicates if they have the same Result and Chart Type.
  • Test Result Definitions that include Trend Chart Definitions must include a During Test Execution OOS Criteria.
  • All Trend Chart Definitions within the same Test Definition Result or Variation must have the same Minimum Spec Execution Count.
  • You can only create Trend Chart Definitions for Test Definitions that are tested on Samples of type Release for Batch Releases or type Stability for Stability Studies.
  • When creating a Regression Trend Chart Definition for a Stability Study, the following also apply:
    • The Spec Data Criteria must be Simple Mode.
    • Each Stability Sample related to the Regression Chart Definition’s Test Definition can have a maximum of 10 distinct Storage Conditions and Orientations.
    • The Result Definition cannot generate more than 10 Results for a single Storage Condition and Orientation.