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Document Change Requests

Document Change Requests (DCRs) provide a formal, traceable process for requesting modifications to effective documents. Anyone with read access to a document can file a DCR; QA reviews and approves or rejects it; an assignee uploads the new version that fulfills the change.

Anyone with documents.read on a document can file a DCR. This includes admins and QA — they are not limited to direct upload, because filing a DCR formally records why the change is needed and lets QA assign someone else to do the work.

On the Versions tab of an effective document, the page offers up to three actions side by side:

  • Request change — opens the DCR submission modal. Available to everyone (one open DCR per user at a time).
  • Upload new version — direct upload, available to admins and QA.
  • Implement approved change — appears for the assignee of an approved DCR. Uploads the new version through the dedicated implementation flow so the action is linked to the DCR in the audit trail.

Document status while a change is in flight

Section titled “Document status while a change is in flight”

The moment the first DCR opens, an effective document transitions to Change Requested. The badge updates immediately so anyone browsing the document can see a change is in progress.

OutcomeDocument status
DCR rejected, no other open DCRs remainReturns to Effective
DCR rejected, other DCRs still pending or approvedStays Change Requested
DCR approved, awaiting implementationStays Change Requested
Assignee uploads the new versionA new draft version starts the normal review/approval flow

Multiple concurrent DCRs are allowed; the document only returns to Effective when none remain open (all rejected, with none approved-but-unimplemented).

  1. On the left sidebar, select Documents.
  2. Open the document you want to request changes for.
  3. Open the Versions tab and select Request change to open the DCR modal.
  4. In Reason for change, explain why a new version is needed. Required.
  5. In Impact (optional), capture regulatory, product, or process implications.
  6. In Proposed changes (optional), outline the edits.
  7. In Suggested assignee (optional), pick the user who should make the change. Leave blank to log the request without naming anyone.
  8. Select Submit Request.

In the Versions tab, the Document change requests panel lists all DCRs.

  1. Select Approve on a pending request.
  2. In the Approve modal, set or change the Assignee if needed. The picker is pre-filled with the suggested assignee from submission.
  3. Select Approve.

The assignee is notified and the request appears on their My Tasks page.

QA can also reassign an already-approved DCR via the Edit assignee action on the row.

  1. Select Reject on a pending request.
  2. Enter a Reason for rejection (required for the audit trail).
  3. Confirm. The requestor is notified and, if no other DCRs are open on the document, the document returns to Effective.

The assignee (or any user with documents.approve as an escape hatch) uploads the new version through the Implement approved change button on the document’s Versions tab.

The upload is recorded against the DCR (status becomes Implemented, with the new version linked) and the document continues through the normal draft → review → approved → effective flow on its new version.

The My Tasks page (/tasks from the sidebar) lists every DCR assigned to you alongside training, deviations, and CAPAs. The dashboard’s Assigned items widget links there too.

FieldRequiredDescription
Reason for changeYesWhy a new version is needed. Drives the QA review.
ImpactNoRegulatory, product, or process impact.
Proposed changesNoOutline of the edits.
Suggested assigneeNoA user to action this change. QA may override at approval time.
  • The Submit button is disabled until Reason for change is filled in.
  • If the API returns an error, an alert appears in the modal with the specific message.
  • Each user may have only one open (pending) DCR per document at a time.
ActionRequirement
Submit a change requestAuthenticated user with documents.read on the document
View own and assigned change requestsAuthenticated user with documents.read on the document
View all change requests on a documentdocuments.approve
Approve / reject / reassigndocuments.approve and role of admin, QA, QA_Team, or QA_Manager
Implement an approved DCRThe assignee, or any user with documents.approve
TriggerRecipients
DCR submittedAll QA users; suggested assignee (if set)
DCR approvedRequestor; final assignee (if set)
DCR rejectedRequestor; previously suggested assignee (if any)
DCR reassignedNew assignee; previous assignee (if any)
DCR implementedRequestor; QA users

Practical example: requesting a change to an effective SOP

Section titled “Practical example: requesting a change to an effective SOP”

Scenario: A production operator notices that SOP-MFG-012 (Autoclave Operation) references an outdated sterilization temperature after a recent equipment upgrade.

  1. On the left sidebar, select Documents and find SOP-MFG-012.
  2. Open the document, switch to the Versions tab, and select Request change.
  3. Reason: “Update sterilization temperature to match upgraded autoclave AC-04. Section 5.3, step 4: change 121 °C / 15 min to 134 °C / 4 min, validated per protocol VP-2026-003.”
  4. Impact: “Affects all 12 production operators trained on this SOP — retraining required.”
  5. Suggested assignee: pick the document’s process owner.
  6. Select Submit.

QA reviews the request, approves it, and confirms the assignee. The assignee receives a notification, opens My Tasks, uploads the corrected SOP via Implement approved change, and the new version enters the normal approval flow.