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Approving Documents in a Workflow

The approval activity is designed to facilitate the formal collection of signatures / approvals for an individual file version. When approving documents, there are three options when completing the task:

  • Approve
  • Do not approve
  • Postpone approval

For documents to be considered “approved” it must pass through a workflow with at least one Approval activity and must be approved by all participants in all activities in the workflow. Only the version of the document that is going through the workflow process is marked as “approved”.

If one of the participants of the approval activity “does not approve” the document(s), then the workflow is automatically terminated. This can happen at any step along the way in a workflow. For example, a file can pass through a first approval activity only to be rejected during a second approval activity. If the participant in the second activity rejects the document the activity is terminated, the workflow is terminated, and the document is flagged as "not approved".

If a version of a document has been marked as “Not Approved”, the system does not allow a workflow to be done on the same document version. Instead, a new version of file will have to be added to the system and the workflow re-initiated. The document needs to go through the entire workflow process before it can be considered approved and complete. Alternatively, the workflow can be restarted on the same version by an initiator or administrator.

There are situations where a document cannot be approved because some conditions have not been met but there is nothing wrong with the document itself. An option called “Postpone Approval” can be used in these conditions. Once the “postpone approval” option is selected, the workflow is immediately terminated and the status of the document will be set to “Approval Postponed”. This option is available only if it has been enabled on the workflow template. If a workflow has the option to postpone approval enabled, then the workflow may be automatically restarted with one of the following options:

  • Return to the workflow initiator. The initiator would need to manually restart or re-initiate the workflow.
  • Automatically return to a previous activity in the workflow template.
  • The user postponing the activity can be given an option of selecting from a list of activities to restart from which includes the returning to the initiator or a previous workflow activities.

This feature is useful when a later workflow activity discovers missing information or documents and needs to return to a previous activity. Participants are notified if a workflow is restarted and includes the comments of the user who postponed the workflow. If the activity is 1 of X, only the participant who completed the previous task is notified. See Creating Workflow Templates for more information.

A document under a workflow approval process can be checked out by a participant if configured in the workflow template. The approval task cannot be completed while a document in the activity is checked out and the document must be checked in before the approval can be submitted.

A feedback document can be attached to any of the approval options. A feedback document is a separate document from the document being approved. It can contain comments or supplemental information. It can be seen in the Workflow Status Report, Review and Approval History (by administrators), and Sign Off Sheet.

Once an approval is submitted, you may need to enter your password to confirm your selected option. This is akin to an electronic signature.

Once a document has been marked as “approved”, it may be converted to a PDF document, and optionally, have workflow information appended to the end of the PDF such as the sign off sheet, approver names, approval date, workflow name, metadata, and so on, after a particular workflow activity has been completed. The following document types can be converted to PDF: docx, doc, dot, docm, dotx, dotm, html, rtf, txt, and pdf. Converter templates are used to define the appended information. One or many templates can be configured, depending on the type of information that is required to be a part of the approved document. Note that for “not approved” or “approval postponed” documents, template information is not appended. An offline document can be used as a part of the workflow and append workflow information. The offline document is converted to an electronic document format and the appended workflow information becomes the document content.

When the system converts a document to a PDF during the workflow process, a new version of the document is added to the library. A global option, “Convert2PdfApproveBothDocumentVersions”, in the web config file in C:\Program Files\FileHold Systems\Application Server\LibraryManager can be configured to allow the option of recording both the source document and the newly created PDF as approved. If this option is not enabled, the new created PDF document will be the only document shown as approved. If it is enabled, the source document will also be marked as approved and both documents will be linked to the signoff sheet and workflow history.

If it is a multiple document workflow, then the approval option selected is applied to all main documents.

To approve a document

  1. Go to Reviews and Approvals > My Tasks and select a workflow where the task is set to Approve.
  2. In the FDA, click Submit Approval from the menu bar.
  • Alternatively, in either the FDA or Web Client, right-click on the task and select Workflow > Submit Approval.
  • In the Web Client, select the check box next to the task name and click Submit Review/Approval from the menu bar.
  1. In the Submit Approval window, select one of the following options:
  • I Approve This Document — The document(s) status changes to “Approved”.
  • I Do Not Approve This Document — The document status changes to “Not Approved” and the workflow is terminated.
  • I Postpone Approval of This Document — The document status changes to “Approval Postponed” and the workflow is terminated. This option is available only if it has been enabled on the workflow template. A window may appear where you are able to restart the workflow from a previous activity or return back to the initiator. Select the option to restart from in the list, if presented, and click OK.
  1. Enter any comments if desired.
  2. If desired, attach a feedback document. Click Browse to locate the file.
  3. To remove the local copy of the feedback document from your computer, select the Remove the local copy… check box.
  4. Click OK.
  5. You may be required to enter your password to approve, postpone or not approve the document. In the Please Enter Your Password window, enter your FileHold password and click OK. This step may be optional depending on the workflow template configuration. See your Library Administrator for details.

Approving documents under a workflow

Note: If you log in to FileHold using a domain (Microsoft Active Directory), enter the same password for logging into your network.

  1. The task is removed from the My Tasks list. If the document was approved and there is another activity in the workflow, then the task moves to the next assigned participant. If the document was not approved or postponed, then the workflow is terminated.
  2. To view the current status of the workflow, see the workflow status report.