Managing changes impacting multiple documents can be complex, especially when ensuring consistency across your eQMS. This can be tedious when bulk changes are required due to circumstances such as corrective actions.
The Document Change Request feature streamlines how related changes are proposed, implemented, and tracked in Qualio. Change requests bundle documents that need updates for improved traceability and oversight throughout the change. Users will also now be able to see if any documents they own are part of a larger change to the QMS.
What is a Document Change Request
Purpose: Easily manage related changes affecting several documents within the Qualio system. This makes tracking the modification of multiple documents far more efficient, while also providing visibility into how each update fits into a larger change within your QMS.
Example Scenario: A CAPA has resulted in the need to update a manufacturing process. This requires updates to multiple work instructions and one procedure to implement the proposed changes. To track the progress of these updates, all documents can be added to a Change Request, and the request owner can monitor the status of all related documents.
What happens when you create a request?
Quick Navigation:
Change Request Workflow
From the Qualio Dashboard, select the Documents tab. Click "Document Change Requests" in the dropdown menu to reach the Change Request list.
If no requests have been created, you’ll be brought to a screen indicating no change requests currently exist. To create your first requests, click the "Create New" button to open the Change Request fields.
Each Change Request has the same fields: Title, Description of Change, Reason for Change, Impact Assessment, and document selection. This template is not editable.
Title: Succinctly describe the total change
Description of change: Detail the change(s) that will be made to selected documents
Approvers: You can also select the necessary Approvers for your Change Request at this stage.
Reason for change: Why is this request being made? Add any context needed, including smartlinks, images, or tables.
Impact assessment: What impact will this change request have to your QMS or processes? Is there any regulatory or product impact?
Documents:
Search for and select the relevant documents to be included in the Change Request.
There is no limit on the number of documents that can be added to a single request.
Qualio will suggest related documents to help you ensure all necessary updates are included.
You can change the document owners directly within the Change Request if needed.
View Linked Documents: Clicking "View linked documents" within this field will open a popup displaying all documents directly connected to the ones included in your Change Request (i.e., any documents that are smartlinked). This helps you quickly identify and add any additional relevant documents.
Note: As documents are added to the DCR, the “View linked documents” option will continue to update to reflect the current linkages.
Bulk Approval (Yes/No): This field allows you to determine if closing the Change Request will trigger the final approval for all included documents, ensuring simultaneous release. Selecting "No" retains the standard individual document approval flows.
Select Approver(s) for your Change Request by searching for and selecting names. All approvers will be Quality users.
When your Change Request is ready, click Send for approval. This will trigger the pre-approval process before the change request can be started/before documents will have new drafts created.
Approvers can Approve or Decline a Change Request.
Both options will require a digital signature. If you choose Decline, a comment is required to explain why the Change Request was rejected.
Once the Change Request has been approved, all documents included will have a draft created for owners to begin working on. You will be able to see the individual document statuses and their versions within the Change Request.
Owners of documents will complete their edits, reviews, and approvals as they normally would. Once all documents have been approved individually, the Change Request owner will select Close Change Request. Change Request closure requires a digital signature.
If Yes was selected for Approve Documents Upon Closure, all documents will become effective.
If No was selected, no change takes place within the Change Control since the documents went through their normal approval process.
Once the Change Request is closed, the status will transition to Closed, and no further changes can be made.
Managing Your Document Change Request
Pre-Approvals
One or more Quality users must be set as Approvers before a Change Request can be moved to In Progress.
Approvers are set in the Properties panel on the right.
Approvers will receive an email notification.
No changes are made to the documents until the approval is completed.
If the Change Request is declined, it must be moved back to the "Draft" status to make changes and then re-sent for approval.
All approval actions are captured in the Audit Trail.
Bulk Approvals
As the DCR owner, you can select Yes to have the DCR serve as the final approval on all included documents.
If you select No (default), individual documents will follow their regular approval flows.
Documents will still move through their standard approval process but remain in For Approval status until the DCR is closed.
If bulk approval is enabled, when the DCR is closed, all included documents will move to the Approved status simultaneously (or Effective if the document is set to become effective upon approval).
All bulk approval actions are tracked in the Audit trail.
Add/Remove Documents
Quality users can add documents of any status to a DCR that’s In Progress.
If an Approved or Effective document is added, a new draft will automatically be created.
Quality users can remove documents from an In Progress DCR with the 3-dot (⋮) menu. This will not delete drafts or affect the current document status.
Linked Documents
After adding documents to a Change Request, you can click the View linked documents option.
A popup will display all documents directly linked to the documents within your Change Request.
Filter the list of documents added to the Change Request to see relationships
Select one or more documents from the list to add them to the Change Request.
Changing Document Owners
While a DCR is in Draft status, the DCR owner can update the owner of any included document.
Ownership changes made within the DCR will only take effect when the DCR is moved to In Progress.
All ownership changes are tracked in the Audit Trail.
Retire Document
Currently, there is no way to retire the existing version. You can only retire that document via the change request by fully up versioning or else you will see that draft document will be unlinked from the DCR.
If version 2.0 is added to the DCR, moves to draft, it must be approved and moved to version 3.0 before it can be retired (click here to review how to retire a document using change request).
DCR Statuses
Draft: This is the initial stage. The DCR owner can edit all fields, add/remove documents, and change document owners. No changes have been made to the included documents.
For Approval: The DCR has been sent for pre-approval. The DCR is now awaiting its approval process.
Approval Declined: A pre-approver declined the DCR. The DCR must be moved back to "Draft" for edits and re-submission.
Attention Required: One or more documents included in the DCR needs to be updated or removed. Clicking into the DCR will display the error explanation and the document(s) will be flagged in red.
In Progress: All pre-approvers have signed off. New drafts of the included documents have been created. You can still add/remove documents but cannot change other DCR fields.
Closed: All included documents have been approved or retired. If bulk approval was enabled, this status change also triggered the final approval for all documents. No further changes are possible to the DCR.
Important Note: All DCR status changes are tracked in the Audit Trail for traceability and compliance purposes.
Searching and Filtering
You can search for Document Change Requests (DCRs) by title or ID. The search results will only display matching DCRs.
Filter the list of DCRs by:
Documents included in the DCR
DCR Owner
DCR Status
Combine filters for refined search results.
Frequently Asked Questions
Who can create a Document Change Request?
Quality users will see the Document Change Request menu option to create new requests. If a document is part of a change request, document owners (Normal or Quality) can view the relevant change request.
When can I close the Change Request?
A Change Request can be closed once all documents have been approved or retired. If there is an outstanding action, the request will remain open, and the closure button won’t be selectable.
What are the Change Request statuses, and what do they mean?
Draft: The Change Request has been started but has not been sent. It can still be edited at this time by the owner.
In Progress: The Change Request has been sent, and selected documents are being updated and approved.
Closed: All selected documents have been updated and are effective, and the DCR owner has closed the Request.
Can I delete or cancel a Change Request?
Yes, if your DCR is in Draft, it can be deleted by the DCR owner.
Can I change the Owner of the DCR?
Yes, any Quality user can use the three-dot menu to change the owner of any Draft or In Progress DCR.
Is there an approval process built into the DCR?
Yes, all DCRs now have an approval process before they are moved to the In Progress status.
What happens if I retire a document that’s part of a Change Request?
The Change Request workflow doesn’t change whether a document is approved or retired - the document(s) will move through the standard lifecycle, and if the document is retired, the DCR owner will be able to close the DCR as they normally would.
How can I retire documents using change request?
Currently, there is no way to retire the existing version. You can only retire that document via the change request by fully up versioning or else you will see that draft document will be unlinked from the DCR.
If version 2.0 is added to the DCR, moves to draft, it must be approved and moved to version 3.0 before it can be retired (click here to review how to retire a document using change request).
Does the Change Request have the ability to bulk-approve documents?
Yes, if you select Yes when choosing whether to approve documents upon closure, all documents will transition to Approved/Effective once the DCR is closed.
Can the DCR feature be used to create new documents?
No, the DCR can only be used for existing documents. If you need to create a new document to be included as part of the DCR, create version 0.1 and then you will be able to add it to the DCR.