Supplier Qualification

The supplier profile page is the central hub for managing a supplier’s qualification lifecycle. It provides a tabbed interface covering general information, classification, qualification records, requirements, documents, SCARs, linked records, and an audit trail.

Profile tabs

Tab	Description
General	Contact details, address, compliance flags, and general information
Classification	Current risk classification and classification history
Qualification	Qualification records with outcomes and requalification dates
Requirements	Assigned qualification requirements with completion tracking
Documents	Uploaded supplier documents (certificates, agreements, audit reports)
SCARs	Supplier Corrective Action Requests linked to this supplier
Linked Records	Related audits, nonconformances, and CAPAs
Audit Trail	Complete history of changes to the supplier record

Change a supplier’s status

1. On the left sidebar, select Suppliers.
2. Select the supplier from the list to open their profile page.
3. In the profile header, select Change Status.
4. From the dropdown, select the new status.
5. Select Save.

Available statuses:

Status	Description
Draft	Initial registration, not yet active
Active	Registered and operational
Qualified	Passed the qualification process
Conditionally Qualified	Qualified with restrictions
Disqualified	Removed from the approved supplier list
Archived	Retained for historical reference only

Create a qualification record

1. On the left sidebar, select Suppliers.
2. Select the supplier from the list.
3. Select Qualify in the profile header, or go to the Qualification tab and select Create Qualification.
4. From the Qualification Type dropdown, select one: Initial Qualification, Periodic Requalification, or For-Cause Requalification.
5. From the Qualification Method dropdown, select the method (options are based on the supplier’s risk classification).
6. In the Qualification Date field, enter or select the date.
7. In the Scope field, describe what was covered in the qualification (required).
8. Under Qualification Outcome, select Approved, Conditionally Approved, or Rejected.
9. If you selected Conditionally Approved, enter the conditions in the Conditions field.
10. In the Justification field, enter the reasoning for this qualification decision (required).
11. Select Submit Qualification.

Requalification alerts

The system monitors requalification dates and displays alerts on the Qualification tab:

• Overdue alert — shown when the next requalification date has passed, with a link to start the requalification process.
• Upcoming alert — shown when requalification is due within 90 days, displaying the number of days remaining.

Auto-assign requirements

1. On the supplier profile, select the Requirements tab.
2. Select Auto-assign Requirements.

The system assigns qualification requirements based on the supplier’s current risk classification, pulling from the configured requirement templates for the corresponding risk category.

Note

Requirements can only be auto-assigned after the supplier has been classified. If no classification exists, classify the supplier first.

View requirement completion progress

On the Requirements tab, a progress bar shows the overall completion percentage (completed or waived requirements divided by total). Below the bar, counts are displayed for completed, waived, and pending requirements.

Requirements table columns

Column	Description
Requirement	Name of the qualification requirement
Category	Requirement category (e.g., documentation, audit)
Status	Current status (Pending, In Progress, Completed, Waived)
Mandatory	Whether the requirement is mandatory for qualification

Upload supplier documents

1. On the supplier profile, select the Documents tab.
2. Select Upload Document (this navigates to the supplier edit page).
3. Upload the document file and fill in the required details.

Documents table columns

Column	Description
Document	Title and document number
Type	Document type (e.g., certificate, agreement, audit report)
Status	Document status
Expiry	Expiration date (if applicable)
Source	How the document was uploaded (internal or external)
Actions	Download button

Tip

Monitor the “Expiring Certs” count on the supplier dashboard to proactively request updated documents from suppliers before their certificates expire.

Create a SCAR

1. On the supplier profile, select the SCARs tab.
2. Select New SCAR.
3. The supplier is pre-selected on the SCAR creation form.

Each SCAR in the list displays its number, title, status, and response due date. Select any row to view the full SCAR detail.

View linked records

1. On the supplier profile, select the Linked Records tab.

The tab displays related quality records from other modules, including linked audits with type, status, and a link to the audit detail page. When no linked records exist, the tab displays a message indicating that records from Audits, NCs, and CAPAs linked to this supplier will appear here.

View audit trail

1. On the supplier profile, select the Audit Trail tab.

The tab provides a complete record of all changes made to the supplier, including who made each change, what was changed, when it occurred, and the reason. Detailed logs can be accessed through the Log Trail module.

Practical example: qualifying and monitoring a contract manufacturer

Scenario: MedDevice Manufacturing Inc. is a contract manufacturer (CMO) producing catheter assemblies for your company. They have been registered and classified as Critical (score 13). You need to complete their initial qualification.

Complete qualification requirements

1. Navigate to Suppliers and select MedDevice Manufacturing Inc.
2. Select the Requirements tab, then select Auto-assign Requirements. The system assigns Critical-tier requirements:
   • On-site GMP Audit (mandatory)
   • Quality Agreement (mandatory)
   • Process Validation Summary (mandatory)
   • Environmental Monitoring Data (mandatory)
   • Business Continuity Plan (non-mandatory)
3. As each requirement is fulfilled, update its status on the Requirements tab. The progress bar advances from 0% toward 100%.

Upload supporting documents

1. Select the Documents tab and select Upload Document.
2. Upload the signed Quality Agreement (PDF), the GMP Audit Report, and the current ISO 13485 certificate with expiry date of 2027-09-15.
3. The Documents tab now lists all three files. The certificate expiry date feeds into the “Expiring Certs” dashboard statistic.

Create the qualification record

1. Select the Qualification tab and select Create Qualification.
2. Fill in the form:
   • Qualification Type: Initial Qualification
   • Qualification Method: On-Site Audit (available because the supplier is classified as Critical)
   • Qualification Date: today’s date
   • Scope: “Full GMP audit of catheter assembly manufacturing, including cleanroom operations, sterilization validation, and packaging. Covers all product lines contracted under Quality Agreement QA-2026-003.”
   • Qualification Outcome: Conditionally Approved
   • Conditions: “Supplier must complete CAPA for Observation #3 (environmental monitoring frequency in cleanroom area B) within 60 days.”
   • Justification: “Audit confirmed compliance with ISO 13485 and 21 CFR 820. One minor observation identified. Risk is acceptable with corrective action timeline.”
3. Select Submit Qualification.

Update supplier status

1. Select Change Status in the profile header.
2. Set the status to Conditionally Qualified.
3. After the supplier resolves the CAPA and you verify effectiveness, change the status to Qualified.

Monitor requalification

The Qualification tab now displays the next requalification date based on the qualification frequency for Critical suppliers. When requalification is due within 90 days, an upcoming alert appears. If the date passes, an overdue alert is shown with a link to start the requalification process.