Generate a final report and approve with an electronic signature

If a final report uses a template that requires an electronic signature, a user with the Report role generates and electronically signs the report. After a final report is published and signed, it cannot be altered.

An analysis that has already been published, indicated by Report Published in the Stage column, cannot be published or signed.

This feature allows you to meet Title 21 CFR Part 11 of Federal Regulations that establishes the United States Food and Drug Administration regulations on electronic records and signatures, password policies, and user activity auditing.

  1. In the Analyses tab, click Overview.
  2. Select the checkbox for the analysis of interest, then click (Actions)Edit Analysis Results. Alternatively, in the Analysis column, click the link for the analysis.
  3. In the Analysis Results screen, select some variants to include in the report.
  4. (Optional) Click  (Add) in the Analysis Results screen to add a note for a variant.
  5. Click Generate Report.

    A report preview is created.

  6. In the Generate Report dialog box, name the organization, then scroll to review the various sections of the report.
  7. Scroll to the bottom of the report, then click Next.
  8. In the Lock and Publish dialog box, enter the user email address and password, enter any comments, then click Publish.

    The report is downloaded in PDF file format.

  9. Open the downloaded PDF file.

    The electronic signature and comment appears only on the first page in the footer of the final report.