The Complaints module handles the recording, evaluation, investigation, and resolution of customer complaints, internal nonconformances, and field actions. It supports full regulatory reporting workflows including FDA, MDR, adverse event, and EU vigilance tracking.
- On the left sidebar, select Complaints.
- Select New Complaint.
- From the Type dropdown, select the record type (Customer Complaint, Nonconformance, or Field Action).
- From the Source dropdown, select the complaint source.
- Enter a Title (required).
- Enter a Description (required).
- From the Classification dropdown, select the nature of the issue.
- From the Severity dropdown, select the severity level.
- From the Priority dropdown, select the priority level.
- For Customer Complaint type records, fill in the Complainant Information section:
- Name, Organization, Email, Phone, and Customer Reference #.
- In the Product / Lot Traceability section, enter product details: Product Name, Product Code, Lot Number, Batch Number, Serial Number, and Quantity Affected.
- In the Dates & Regulatory section, set Date Occurred, Date Reported by Customer, and Due By (SLA Deadline).
- Under Regulatory Reporting Flags, check any that apply: Reportable to FDA, MDR Reportable, Adverse Event, EU Vigilance Reportable.
- In the Immediate Action section, describe any containment or corrective actions already taken.
- Select Create Complaint.
- On the left sidebar, select Complaints.
- To search by complaint number or title, enter text in the Search complaints field.
- To narrow results, use any combination of these dropdowns:
- All Statuses — filter by workflow status.
- All Types — filter by record type (Customer Complaint, Nonconformance, Field Action).
- All Sources — filter by complaint source.
- All Severities — filter by severity level.
- To open a complaint, select its row in the table or select View in the Actions column.
- On the left sidebar, select Complaints.
- Select the complaint you want to advance.
- In the header area, select the appropriate transition button:
| Current Status | Available Transitions |
|---|
| Received | Start Evaluation, Reject |
| Under Evaluation | Start Investigation, Skip to Resolution |
| Investigation | Move to Resolution |
| Resolution | Submit for Closure |
| Pending Closure | Close Complaint |
- On the left sidebar, select Complaints.
- Select the complaint you want to reject.
- In the header area, select Reject.
- In the Reject Complaint form, enter the Reason for rejection (required).
- Select Confirm Rejection.
- On the left sidebar, select Complaints.
- Select the nonconformance record you want to disposition.
- In the Disposition section, select Set Disposition.
- From the Disposition dropdown, select one of the following:
| Disposition | Description |
|---|
| Use As-Is | Accept the nonconforming material/product for use |
| Rework | Material/product can be corrected through rework |
| Scrap | Material/product must be destroyed |
| Return to Vendor | Return to the supplier |
| Quarantine | Hold pending further evaluation |
- Enter a Justification (required).
- Select Save Disposition.
- On the left sidebar, select Complaints.
- Select the complaint you want to update.
- In the Resolution & Root Cause section, select Edit.
- Enter the Root Cause Summary.
- Enter the Resolution.
- Select Save.
- On the left sidebar, select Complaints.
- Select the complaint you want to comment on.
- In the Comments section, enter your comment in the text field.
- Select Post.
| Type | Description |
|---|
| Customer Complaint | Complaint received from an external customer |
| Nonconformance | Internally identified quality deviation (supports dispositions) |
| Field Action | Issue identified in the field requiring corrective action |
| Source | Description |
|---|
| Customer | Directly from a customer |
| Field Report | Identified through field monitoring |
| Regulatory | Originated from a regulatory body or inspection |
| Internal | Found through internal processes |
| Supplier | Reported by or related to a supplier |
| Severity | Description |
|---|
| Critical | Severe impact, immediate patient risk |
| High | Significant quality or safety concern |
| Medium | Moderate impact, requires investigation |
| Low | Minor issue, limited quality impact |
Complaints can be further classified by the nature of the issue:
- Product Quality
- Safety
- Labeling
- Packaging
- Performance
- Delivery
- Service
| Flag | Description |
|---|
| Reportable to FDA | Complaint requires FDA notification |
| MDR Reportable | Medical Device Report required |
| Adverse Event | Classified as an adverse event |
| EU Vigilance Reportable | Requires reporting under EU vigilance requirements |
This section only appears for Customer Complaint type records:
| Field | Description |
|---|
| Name | Customer contact name |
| Organization | Company or organization |
| Email | Contact email address |
| Phone | Contact phone number |
| Customer Reference # | The customer’s own reference number for the complaint |
The complaint list page displays four summary statistics at the top:
| Metric | Description |
|---|
| Total | Count of all complaint records |
| Open | Complaints not in Closed or Rejected status |
| Overdue | Open complaints past their SLA due date |
| Regulatory | Complaints flagged for any regulatory reporting (FDA, MDR, or Adverse Event) |
From the API, complaints support linking to related quality records:
- Deviations — link a complaint to a related deviation
- CAPAs — link a complaint to a corrective/preventive action
- SCARs — link a complaint to a supplier corrective action request
These links maintain traceability between related quality events across the system.
