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Review and Approve eTMF Documents with Quality Control Workflows

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eTMF Quality Control workflows allow you to review and approve your study documents to ensure that they are accurate, compliant, and ready to be filed in your TMF. This article describes how to configure Quality Control workflow settings and permissions, how to perform a QC workflow, and how to visualize your study quality with oversight metrics. 

Define Quality Control Settings for Your Study

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Study Managers and eTMF Administrators can navigate to the Study Configuration page to manage the following two settings:

  • Auto Approve Documents: Checking this box will cause all new study documents to be automatically promoted to the Approved status upon creation, without requiring a QC review. Leaving this box unchecked will require documents to be manually approved through a QC review.
  • Default QC Due Date: This number determines how many days may pass before a document is considered overdue for approval. Overdue reviews will impact notifications and study metrics. “Auto approve documents” must be disabled in order to modify this setting. 

Assign Roles for Performing Quality Control Reviews

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The Quality Control feature introduces a new role to eTMF Study Configuration: “Approvers.” These are the individuals who may provide a verdict in an eTMF document’s QC workflow to either Approve or Reject the document when auto-approval is disabled for the study. 

Users in this group have the following permissions:

  • View filing level details
  • View filing level milestones
  • View filing level dashboard
  • View filing level artifact & document statuses
  • View unapproved filing level documents
  • View approved filing level documents
  • Reject & approve filing level documents in QC
  • View QC comments on filing level documents
  • Add QC comments to filing level documents

eTMF Administrators and Study Managers can add users to the “Approvers” group by adding a group which contains that user to the “Approvers” field on the Permissions tab of the Study, Country, or Site Configuration page. 

Initiate and Perform a Document Quality Control Review

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When auto-approval is disabled for a study, documents are created in the “Draft” state and must be approved manually by a user with the Approver role. In order to be approved, QC must be initiated. 

Filing Level Uploaders, Filing Level Managers, Study Managers, and eTMF Administrators can initiate QC for a Draft study document by clicking “QC ready” from the “Quality control” tab of the document preview page.

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Once QC is initiated, the document status will change to “In QC.” Document Approvers will now have the ability to Reject or Approve the document, until which point the document will be included in a daily digest email sent to document Approvers which contains a list of pending documents to review.

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When an Approver views an “In Progress” document, they can “Reject” or “Approve” the document by clicking the corresponding button on the “Quality Control” tab of the document preview page. Users will be prompted to provide their username, password, and a reason for change when delivering their verdict. The system will send an email to the Approver and Uploader when a document changes status, except for the Approver who initiated the status change.

A “Reject” verdict will change the document status to “Rejected.” Once Rejected, a document can be returned to the “Draft” state when a Filing Level Uploader, Filing Level Manager, Study Manager, or eTMF Administrator uploads a new version of the file. Once a document is in “Draft,” QC can be initiated once again. 

An “Approve” verdict will promote the document to an “Approved” state and make the document visible to users with the Filing Level Viewer permission.

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The “Quality control” tab also provides a venue for users to add comments. This allows stakeholders to communicate regarding any quality issues discovered. When a document is Rejected, the reason for change is captured as a comment. The system will send an email to the Filing Level Approver, Filing Level Uploader, and anyone mentioned in the comment upon the addition of a QC comment to a document.

Monitor Study Quality with Oversight Metrics

Users can quickly understand the current state of their QC review efforts by reviewing Quality Status metrics on the Study, Country, and Site Dashboards.

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The first widget displays a pie chart of all of the uploaded documents for the selected filing level, by current Status. 

The second widget displays the timeliness of the documents that are currently unapproved (Status = Draft, In QC, or Rejected). Documents with a due date (as determined by the “Default QC due date” setting) prior to the current date will count as “Overdue”; else, they count towards “Due.” 

Address a Common Quality Issue by Reclassifying Documents

One of the most common quality issues that we see here at Egnyte is documents which have been filed to the incorrect artifact. As a part of this feature, we are including functionality to allow Filing Level Uploaders to reclassify a misclassified document.

Reclassify a document by navigating to the Viewer tab of the Dashboard, selecting the “Action” button next to a document, and selecting “Reclassify.”

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