Completing a Periodic Review

You can verify that you completed the periodic review of a released quality system document. You must be either the Subject Matter Expert or the Temporary Subject Matter Expert assigned to the periodic review.

Important: This app uses electronic signatures to provide an audit trail for certain approvals, as is often required in highly-regulated industries. You cannot delete or modify the personal data contained in the electronic signatures. You should carefully review your use cases associated with electronic signatures to ensure that the specific business requirements associated with them are being met, while still adhering to good personal data management practices.

Before you begin:

The ESIGN (one-step validation) is enabled and the 'This approval requires an electronic signature' page is appeared if,

  • The context object has the route and the value is specified to true for the Requires ESign attribute of the context route object.
  • The context object does not have the route,
    • The global E-Signature value is configured as ‘Required for approval tasks’ or ‘Specified in route template’.
    • The global E-Signature value is configured as ‘Not required for approval tasks’, the 'This approval requires an electronic signature' page is not appeared.

  1. Select the quality system document to be reviewed using one of these methods:

    1. View the My Periodic Reviews tab. See My Periodic Reviews.
    2. If you do not see the Periodic Review action, select View > Pending Review on the My Periodic Reviews page toolbar.
    3. Select the quality system document to be reviewed.
    4. Click Periodic Review .

    or

    View the quality system document's Properties page.

  2. Click Periodic Review or select Actions > Periodic Review > Periodic Review .

    If any files are checked out of the quality system document, the app shows an error message. If a file is checked out, it could indicate that changes are in process. If no changes need to be made, check the file back in and continue with the next step.

  3. Select the disposition for the quality system document's periodic review:
    • Keep Released means that the quality system document is up-to-date and no changes are required.
    • Changes Required means that the quality system document is no longer correct and needs to be revised. It will remain for periodic review until a revision is initiated or the quality system document's state is changed to Obsolete.
  4. If changes are required, from the Create Change list, select which type of change object you want to create for the required revisions:
  5. Enter your comments about the periodic review in the Review Summary field, if applicable.
  6. Click Done.
  7. If ESIGN is enabled, you can validate the periodic review using two factor authorization. From the User Verification dialog box, enter your 3DEXPERIENCE ID and password.
  8. Select the check box to confirm that your electronic signature is the equivalent to your handwritten signature.
  9. Click Validate.
    Once your credentials are verified, the 3DEXPERIENCE - Access Control dialog box opens.
  10. Enter the code that you received on the configured device.
  11. Click Validate.

If you selected Changes Required as the disposition, the app sets the Last Periodic Review Date to the current date. It keeps the Next Periodic Review Date the same as it was. The "Periodic Review Disposition" entry on the Audit Trails page for the object is updated with the disposition and current date.

If you selected Keep Released as the disposition, the app does all of the following:

  • Keeps the quality system document in the Released state.
  • Sets the Last Periodic Review Date to the current date.
  • Calculates the Next Periodic Review Date based on the periodic review interval.