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LS Medical Product Issue RR Submit Workflow


This workflow is initiated from the Generate button on the Regulatory Reports screen.

The workflow appears in Figure 16.

Figure 16. LS Medical Product Issue RR Submit

Workflow Description. This workflow performs the following actions:

  1. Checks if the application is running on a server database. If not, the workflow ends.
  2. Checks if the user is the primary owner. If not, the workflow ends.
  3. Checks if the record has already been processed. If it has, the workflow ends.
  4. Calls the LS Medical User Verification workflow. If the authentication does not pass, the workflow ends.
  5. Checks if the parent product issue already has a report number.
    If the product issue. . .
    and the Report Type Is. . .
    Then. . .

    Has a report record with a report number

    Use the same number for the report being submitted.

    Does not have a report record with a report number

    3500A or MDV

    Generate a new report number.

    3500A Supplemental or MDV Follow-up

    The workflow ends.

  6. Sets the status of the report to Submitted.
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