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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.

  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.
  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.

If you find yourself setting the same search text and filters every time you open the register, save them as a named view instead of rebuilding them.

  1. On the left sidebar, select Suppliers.
  2. Set the search text and filters you want to save.
  3. Select Views in the toolbar, then select Save current view….
  4. Enter a name and select Save.

To reapply a saved view, select Views and choose it from the list – the search text and every filter it was saved with are restored together. To remove one you no longer need, select the trash icon next to it in the list.

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

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
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.

Practical example: onboarding a new packaging supplier

Section titled “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 select Sign & Submit — approving a supplier is an electronic-signature event, so a verification-code step confirms the decision before the record is created.

  5. Status updates automatically. Recording the qualification decision in step 4 is what sets the supplier’s status — Qualified, Conditionally Qualified and Disqualified are outcomes of a qualification decision, not a manual choice. PackSecure now appears in the supplier list with a “Major” risk badge and “Qualified” status. The manual Change Status control (profile header) only covers Draft → Active; a supplier that later fails a requalification is moved to Disqualified the same way, by recording that outcome.

  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.