Validation status and lifecycle stages

To install an object in the Quality Control or Production lifecycle stage, you must first promote it to the corresponding validation status.

  1. On the Icon is a house. Home page or Icon shows a clipboard.Study Manager interface select the study and the Development lifecycle stage.

  2. After you select a study, click the Study Configuration icon Shows gear with pencil iconfrom the navigation bar.

  3. Click the tab for the type of object you want to change the status of:

    • Clinical Data Models

    • Transformations

    • Validation Checks

  4. Select the object and select Modify Validation Status from the Actions drop-down.

    Tip:

    The object must be checked in and installed.

  5. From the Validation Status drop-down list, select the new status.

    • Development: Assigned by default to all new and checked out objects.

    • Quality Control (QC): (Optional, corresponds to UAT in InForm.) For objects that are undergoing formal testing.

    • Production: For objects that are suitable for use in an active study. The system prevents destructive changes to tables and models in a production environment.

  6. (Optional) Click the Icon is a plus sign.Add icon in the Supporting Documents pane to add a document such as test results, a log file, a requirements document, or a signoff document.

  7. Click OK.

    Note:

    When a transformation is promoted to QC or Production, the system automatically promotes its source and target models to the same lifecycle stage.

  8. Install the object in the new lifecycle stage:

    1. At the top of the page, change the lifecycle context to the same as the object's new validation status.

    2. Select and install the object.

      Tip:

      In QC and Production you can choose to display either latest installed version or an installable version, if any—a newer version that has been installed in a lower lifecycle and promoted to the current lifecycle but not yet installed in the current lifecycle.