Approval Workflow

The approval step is where authorized decision-makers review a change request along with its impact assessments and render a formal decision. The approval decision determines whether the change proceeds to implementation, is rejected, or is conditionally approved with additional requirements.

Submit an approval decision

1. On the left sidebar, select Change Control.
2. Select the change request requiring approval to open the change detail page.
3. In the Approval Workflow section, select Create Approval.
4. From the Approval Level dropdown, select your authority level (required).
5. From the Decision dropdown, select one: Approved, Rejected, or Conditionally Approved (required).
6. In the Comments field, enter any comments, conditions, or rationale for your decision (optional but strongly recommended for rejections and conditional approvals).
7. Select Submit Decision.

The page header displays the change number and title of the request being evaluated.

Approval levels

Level	Typical Authority
Department Manager	Approves changes within their department’s scope
Quality Assurance	Reviews quality impact and compliance considerations
Regulatory	Evaluates regulatory implications and required submissions
Executive	Final authority for high-impact or cross-functional changes

Note

Some change requests may require approval at multiple levels. For example, a process change affecting product quality may need approval from both the Department Manager and Quality Assurance.

Decision options

Decision	Effect
Approved	The change is approved and can proceed to implementation
Rejected	The change is not approved. The request status moves to Rejected.
Conditionally Approved	The change is approved subject to conditions specified in the comments. Conditions must be addressed before implementation.

Caution

When selecting “Conditionally Approved,” always include the specific conditions in the Comments field. This ensures the change requestor and implementation team understand what must be addressed.

Status transitions

The approval decision directly affects the change request lifecycle:

Submitted / Under Review
        |
        +-- Approved -----------> Approved (ready for implementation)
        |
        +-- Rejected -----------> Rejected (change is not proceeding)
        |
        +-- Conditionally ------> Approved with conditions
            Approved               (conditions noted in comments)

After approval, the change proceeds through:

1. Implementation — The approved change is put into effect.
2. Verification — The implementation is verified against the plan.
3. Closure — The change record is formally closed.

After submitting a decision

After submitting your approval decision:

1. A success message confirms the decision was recorded.
2. You are automatically redirected to the change detail page.
3. The decision is recorded with your identity, timestamp, and comments.
4. The change request status updates based on the decision.
5. The requestor and relevant stakeholders can see the decision.

Best practices

• Review all impact assessments before making a decision.
• Provide clear comments explaining the rationale for rejections.
• For conditional approvals, list specific and measurable conditions.
• Verify that the implementation plan and rollback plan are adequate before approving.
• Consider whether training requirements have been identified for the change.

Practical example: Multi-level approval for a document change

A pharmaceutical company is revising its batch record template (SOP-BR-001) to add an in-process control checkpoint for tablet weight verification. The change request CC-055 has completed impact assessment with a risk score of 4 (medium). Two approval levels are required.

Department Manager approval

The production department manager reviews the change request and assessments.

1. They open CC-055 and select Create Approval in the Approval Workflow section.
2. They complete the form:
   • Approval Level: Department Manager
   • Decision: Approved
   • Comments: “Reviewed technical assessment and implementation plan. The additional weight check at the 30-minute mark aligns with our process improvement goals from the annual product review (APR-2025-TAB). Production schedule impact is minimal — estimated 8 minutes additional time per batch. All 14 production operators will need training before go-live. Approved from a production operations perspective.”
3. They select Submit Decision.

Quality Assurance approval

The QA manager reviews the same request along with the Department Manager’s approval.

1. They open CC-055 and select Create Approval.
2. They complete the form:
   • Approval Level: Quality Assurance
   • Decision: Conditionally Approved
   • Comments: “The additional in-process control is appropriate and consistent with ICH Q7 Section 8.30 guidance. However, the following conditions must be met before implementation: (1) Update the sampling plan document SP-TAB-003 to include the new checkpoint data recording requirements. (2) Add the weight verification acceptance criteria (target +/- 5% of label claim) explicitly to the batch record template rather than referencing the specification document. (3) Complete OQ protocol for the revised batch record workflow in the electronic batch record system.”
3. They select Submit Decision.

The change requestor addresses each condition, updates the implementation plan, and the change proceeds to implementation once all conditions are satisfied.