Submitting Change Requests

Create a new change request

1. On the left sidebar, select Change Control.
2. Select New Change Request.
3. In the Title field, enter a brief, descriptive title for the change (3—200 characters, required).
4. In the Description field, enter a detailed description of the proposed change (at least 10 characters, required).
5. From the Change Type dropdown, select one: Document, Process, Equipment, System, or Supplier (required).
6. From the Priority dropdown, select one: Critical, High, Medium, or Low (required).
7. In the Reason for Change field, explain why this change is needed (at least 10 characters, required).
8. Optionally, in the Assign To field, enter a user ID to assign the change request to a specific person.
9. Select Create Change Request.

Caution

All required fields must pass validation before the form can be submitted. The system displays specific error messages if validation fails — for example, if the title is too short or the reason is missing.

Edit an existing change request

1. On the left sidebar, select Change Control.
2. In the change control list, select the edit icon (pencil) on the change request row.
3. Update the fields as needed.
4. Select Save Changes.

Note

Only the original requester or an administrator can edit a change request.

Additional fields available when editing

The edit form includes all fields from the creation form plus the following fields for planning purposes:

Field	Description
Affected Areas	A comma-separated list of areas impacted by the change (e.g., Production, Quality, Regulatory)
Estimated Effort	A description of the expected effort (e.g., “2 weeks”, “40 hours”)
Estimated Cost	A numeric cost estimate in dollars
Implementation Plan	A step-by-step description of how the change will be implemented
Rollback Plan	A description of how to revert the change if issues arise
Verification Method	How the change will be verified after implementation
Training Required	A checkbox indicating whether training is needed for this change

Tip

Completing the implementation details early helps assessors and approvers make informed decisions. Fill in the implementation plan, rollback plan, and verification method whenever possible.

Priority levels

Priority	When to Use
Critical	Safety-related changes or issues requiring immediate action
High	Changes with significant business or compliance impact
Medium	Standard changes with moderate impact
Low	Minor improvements or cosmetic changes

What happens after submission

After a change request is created:

1. The system assigns a unique change number automatically.
2. The request status is set to the initial lifecycle state.
3. You are redirected to the change detail page.
4. The change appears in the Change Control list for all users to view.
5. Authorized assessors can proceed with an impact assessment.

Practical example: Submitting a process change

A quality engineer needs to modify the environmental monitoring frequency in a sterile filling suite from weekly to twice-weekly sampling after a recent trend analysis showed seasonal bioburden fluctuations.

1. The quality engineer navigates to Change Control and selects New Change Request.
2. They complete the creation form:
   • Title: “Increase Environmental Monitoring Frequency in Filling Suite B”
   • Description: “Modify environmental monitoring SOP-EM-012 to increase viable air sampling and surface monitoring frequency in Filling Suite B (ISO 5) from weekly to twice-weekly (Monday and Thursday). This change applies to all 12 sampling locations defined in the room qualification protocol.”
   • Change Type: Process
   • Priority: High
   • Reason for Change: “Trend analysis of environmental monitoring data from Q3-Q4 2025 (EM reports EM-2025-Q3-014 and EM-2025-Q4-008) identified seasonal bioburden increases approaching alert levels at locations FS-B-04 and FS-B-09 during summer months. Increasing monitoring frequency will provide earlier detection and support proactive contamination control per EU GMP Annex 1 requirements.”
3. They select Create Change Request and the system assigns change number CC-051.
4. They then edit the request to add implementation details:
   • Affected Areas: Production, Quality Control, Microbiology Lab
   • Implementation Plan: “1. Revise SOP-EM-012 to reflect twice-weekly schedule. 2. Update sampling schedule in LIMS. 3. Train all 6 EM technicians on revised schedule. 4. Begin new frequency effective first Monday after training completion.”
   • Rollback Plan: “Revert SOP-EM-012 to previous version and restore weekly sampling schedule in LIMS. No product impact expected from reverting frequency.”
   • Verification Method: “Confirm twice-weekly sampling is executed for 4 consecutive weeks. Verify data is captured in LIMS for all 12 locations on both scheduled days.”
   • Training Required: Yes (checked)
5. The change request is now ready for impact assessment.