Document Control

Start Routing Process and Sign the DMS Item

OVERVIEW

Users can Start the Routing Process and sign the DMS items in Document Control Project.

TO START ROUTING PROCESS FOR DMS ITEM
  • Select the Document Control Icon from Main Menu
  • Select the DMS Item for which, the routing process needs to be started.

If the revision file added is in PDF, XLSX, PPT, or DOCX format, the system will first generate a PDF preview.

In case a PDF Preview is generated immediately, the user will see the Blue Start Routing button

In case the PDF Preview is not generated immediately, the user will see the Gray Start Routing button

  • Click on the Gray Start Routing button.

A pop-up appears with the message, “The PDF is currently being generated.”

If the PDF is generated within 45 seconds, the gray “Start Routing” button will automatically change to blue.

If the PDF is not generated within 45 seconds, the gray “Start Routing” button will still change to blue. However, when the user clicks on the “Start Routing” button at this point, a pop-up will appear, prompting the user to generate the PDF manually.

  • Click on Start Routing button now
  • On the Start Routing Popup Window following fields are displayed:
    • Select Process: Select the routing process from the Select Process dropdown list.
    • Is Default Process for Selected Item: To make the select/unselect process as the default, select/unselect this checkbox.
    • Include Logo on Cover Letter: To display/Hide the Logo on the Cover Letter, select/unselect this checkbox.
    • Distribution: To send the emails to the users
      • Lists: Select the list from the users distribution lists.
      • Emails: Type the emails of specific users, internal or external.
    • Comments: Enter any notes in the Comments field.
    • Advance link: Under the Advance link, you can manage the list of signers (Edit, Remove or Order ), adding a signer is done from the Add Signer button
    • Start/Cancel: Click on Start. This changes the status of the work item to In Work in the Revisions tab and a mail is triggered to the approver/s.
TO SIGN THE DMS ITEM
  • Signers receive an email with the sign hyperlink which redirects to the DMS item detail page, or they can directly open the detail page from the system.
  • On DMS Detail Page, Sign and Cancel Routing buttons are displayed.
  • Cancel Routing: To cancel the Routing Process, click on Cancel Routing.
  • Sign: To Sign the DMS Item, click on Sign button. The following fields are displayed on the signing page.
    • Item: Displays the Item name hyperlink.
    • Revision: Displays the revision number of the item.
    • Username: Enter the username which needs to sign the item.
    • Password: Enter the password of the user account.
    • Comments: Enter the comments if any in the textbox.
    • Approve: Click on the Approve button if the user wants to approve the item.
    • Reject: Click on the Reject button if the user wants to reject the item. (Comment is mandatory)

1. As per the 21cfr part 11, you cannot save the Username and Password to sign the document.

2. If there is another level of approver, an email is triggered to the next approver and the approver has to sign it to complete the routing process.

3. Also, cover letters are generated at each stage during the routing process. Refer to Cover Letter for more information.

4. Approving or Rejecting with SSO ( single Sign on) is displayed if SSO is enabled on the system.

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