Supplier Management

The Supplier Management module provides a centralized registry for managing suppliers throughout their lifecycle — from registration through classification, qualification, and ongoing monitoring. It integrates with SCARs, audits, and document management to give you a complete view of supplier quality performance.

View the supplier list

1. On the left sidebar, select Suppliers.
2. Review the dashboard statistics at the top of the page: Total Suppliers, Qualified, Expiring Certs, Overdue SCARs, and Requalification Due.
3. Below the statistics, review the risk category breakdown showing counts for Critical, Major, Minor, and Non-Critical suppliers.
4. Scroll down to the supplier table, which shows each supplier’s number, name, type, risk category, status, and country.

Filter and search suppliers

1. On the left sidebar, select Suppliers.
2. Use the filter controls above the supplier table:
   • Enter text in the Search suppliers… field to search by supplier name, supplier number, or country.
   • Select a value from the All Statuses dropdown to filter by lifecycle status.
   • Select a value from the All Risk Categories dropdown to filter by risk classification.
   • Select a value from the All Types dropdown to filter by supplier type.

Register a new supplier

1. On the left sidebar, select Suppliers.
2. Select New Supplier in the top-right corner.
3. Complete the multi-step registration form with the supplier’s details: name, type(s), country, contact information, and classification.
4. Select Save to register the supplier.

View a supplier profile

1. On the left sidebar, select Suppliers.
2. Select any row in the supplier table, or select View in the Actions column.
3. Review the supplier’s full profile, including qualifications, documents, SCARs, and audit history.

Open supplier settings

1. On the left sidebar, select Suppliers.
2. Select Settings in the top-right corner.
3. Configure supplier management options in the Admin panel.

Supplier statuses

Status	Description
Draft	Initial state after registration, not yet active.
Active	Supplier is registered and operational.
Qualified	Supplier has passed the qualification process.
Conditionally Qualified	Qualified with conditions or restrictions.
Disqualified	Supplier has failed qualification or been removed.
Archived	No longer active, retained for historical records.

Supplier types

Suppliers can be assigned one or more of the following types:

• Manufacturer
• Contract Manufacturer (CMO)
• Raw Material Supplier
• API Supplier
• Component Supplier
• Packaging Supplier
• Sterilization Provider
• Calibration Service
• Laboratory / Testing
• Software / IT / Cloud
• Logistics / Transport
• Consultant / Service Provider

Supplier table columns

Column	Description
Supplier #	Auto-generated unique identifier.
Name	Legal name of the supplier.
Type	Supplier type(s); shows the first two with a count for additional types.
Risk	Risk category badge, or “Not classified” if not yet assessed.
Status	Current lifecycle status.
Country	Country of registration.
Actions	Link to view the supplier profile.

Tip

Use the risk category breakdown cards above the table to quickly identify the distribution of critical vs. non-critical suppliers in your registry.

Practical example: onboarding a new packaging supplier

Scenario: Your company needs to qualify a new packaging supplier, PackSecure GmbH, that will provide primary packaging for a sterile medical device.

1. Register the supplier. Navigate to Suppliers and select New Supplier. Enter “PackSecure GmbH” as the legal name, select Germany as the country, and check Packaging Supplier under supplier types. Select the EU and US regulatory regions since the packaged product ships to both markets. Complete the address and contacts steps, then submit.

2. Classify the supplier. Open the newly created supplier profile and select Classify. Because primary packaging directly contacts the sterile device, rate Impact on Product Quality as High, Impact on Patient Safety as High, Regulatory Impact as Medium, Process Criticality as Medium, and Data Integrity Risk as Low. The estimated score of 11 places PackSecure in the Major risk category. Enter a justification such as “Primary packaging for sterile device; failure could compromise sterility barrier” and submit.

3. Auto-assign requirements. On the Requirements tab, select Auto-assign Requirements. The system assigns requirements based on the Major risk category, such as ISO 11607 certification, supplier audit, and quality agreement.

4. Qualify the supplier. After completing the requirements, go to the Qualification tab and select Create Qualification. Choose Initial Qualification, enter the scope (“Primary packaging materials for SterilGuard device line”), select Approved as the outcome, and submit.

5. Change status. Select Change Status in the profile header and set the supplier to Qualified. PackSecure now appears in the supplier list with a “Major” risk badge and “Qualified” status.

6. Monitor ongoing quality. The supplier dashboard shows PackSecure in the Major category count. If an incoming inspection reveals a defect in seal integrity, create a SCAR from the supplier’s SCARs tab, selecting Incoming Inspection as the source. The SCAR tracks PackSecure’s root cause analysis and corrective action through to effectiveness verification.