Vendors

Clarix includes a Vendor management module for tracking the raw material suppliers your facility sources from. In a 503B sterile compounding environment, every API and excipient must come from a qualified supplier. Maintaining vendor qualification records in Clarix creates a direct link between your approved vendor list and the lots you receive, supporting FDA traceability requirements and making compliance audits faster.

Role required: QA Officer or Admin can create, edit, and qualify vendors. All authenticated roles can view vendor information.

---

Why vendor qualification matters for 503B

Under FDA guidance for 503B outsourcing facilities, you must:

1. Qualify each API and excipient supplier before using their materials in compounding
2. Maintain records of the qualification basis (audit, questionnaire, COA history, etc.)
3. Verify each incoming lot against the approved supplier's COA
4. Maintain an Approved Vendor List (AVL) that QA reviews and approves on a defined schedule

Clarix's Vendor module provides the digital backbone for your AVL. By linking lot records to vendor records, Clarix can flag incoming lots from unqualified or deactivated vendors, and your quality team can see at a glance whether a material source is on the approved list.

---

Approved Supplier List (ASL)

The Approved Supplier List (ASL) is the formal, QA-approved register of vendors that have met your facility's qualification criteria for supplying APIs, excipients, components, and packaging materials. Under 21 CFR 211.84, all incoming components must be received from suppliers whose identity and reliability have been established, and tested or examined appropriately before use in compounded sterile preparations.

Clarix surfaces the ASL as a filtered view of the vendor catalog — showing only vendors with Qualified status — and augments each vendor record with the additional fields required to support a complete supplier qualification dossier.

ASL-specific fields

The following fields are available on each vendor record to support your formal ASL program. Access them from the vendor detail page under the Qualification tab:

Printing the ASL

To generate a dated, QA-signed Approved Supplier List for your regulatory file:

1. Navigate to Inventory → Vendors.
2. Click ASL View in the toolbar to filter to Qualified vendors only.
3. Click Export ASL PDF.
4. Enter the QA Manager's Facility PIN to certify the list.
5. The PDF is downloaded with the facility name, generation date, certifying QA Manager identity, and all Qualified vendor entries.

The exported ASL PDF should be retained in your quality records and refreshed whenever a vendor is added, qualified, or disqualified. FDA investigators may request your current ASL during an inspection.

21 CFR 211.84 incoming material controls

When a lot is received from a vendor, Clarix checks the vendor's ASL qualification status before allowing the lot to be released from quarantine to production:

---

The vendor catalog

Navigate to Inventory → Vendors to see all vendor records. The vendor catalog shows:

Use the Qualification status filter to quickly identify vendors pending review or that have been conditionally qualified.

---

Creating a vendor

1. On the Vendors page, click New Vendor.
2. Fill in the vendor creation form:

Contact information

Address

The address is particularly important for FDA Drug Supply Chain Security Act (DSCSA) compliance and for locating the supplier during audits.

Qualification status

Check the Qualified checkbox in the form if the vendor has already completed qualification. You can update this later.

Notes

Use the Notes field to document:

• The basis for qualification (e.g., "Qualified per audit QA-V-2025-003, September 2025")
• Any conditional requirements (e.g., "Conditional approval — require independent COA verification for each lot of Famotidine USP")
• Re-qualification schedule (e.g., "Annual re-qualification due Q3 2026")

3. Click Create vendor.

---

Vendor detail page

Click any vendor to open its detail page, which contains:

Materials tab

Lists all inventory items in Clarix that have been linked to this vendor. An item is linked to a vendor when a lot is received with that vendor selected. From this tab you can see:

• Every material sourced from this vendor
• The most recently received lot for each material
• Aggregate on-hand quantity from this vendor's lots

Purchase history tab

A chronological list of every lot received from this vendor, with columns for:

• Lot number
• Material (item name)
• Date received
• Quantity
• COA assay
• Current lot status

This gives QA a complete receiving history for the vendor, useful during re-qualification or in response to a quality concern.

Documents tab

Attach qualification documents directly to the vendor record:

• Audit reports
• Supplier questionnaires
• Quality agreements
• FDA Form 483 responses
• GMP certificates

Accepted formats: PDF, DOCX, XLSX. Maximum file size: 25 MB per document.

---

Editing a vendor

1. Open the vendor detail page.
2. Click Edit vendor in the header.
3. Update the fields as needed.
4. Click Save.

All changes are logged in the vendor's audit trail.

---

Deactivating a vendor

When a vendor is no longer approved for sourcing — whether due to failed re-qualification, a quality incident, or a business decision — you should deactivate them rather than delete them.

1. Open the vendor detail page.
2. Click Edit vendor.
3. Toggle Active to disabled.
4. Update Qualification status to Disqualified if appropriate.
5. Add a deactivation note in the Notes field.
6. Click Save.

Effect of deactivation:

• The vendor no longer appears in the vendor dropdown when receiving new lots
• Clarix displays a warning when viewing any quarantined lot from a deactivated vendor
• Existing released lots from the vendor are not automatically quarantined — you must separately review and action any in-stock material from a deactivated or disqualified vendor
• The vendor record is retained permanently for audit purposes

---

Linking vendors to lots

When receiving a lot, you can optionally select the vendor from the vendor dropdown in the receive lot form. Linking the vendor:

• Associates the lot with the vendor's qualification record
• Makes the lot appear in the vendor's purchase history
• Enables the system to warn when a lot is from a conditionally qualified or disqualified vendor

If a vendor is not yet in Clarix when you receive a lot, you can create the vendor record first and then receive the lot, or receive the lot without a vendor link and link it later from the lot detail page.

---

Related pages

• Receiving Lots
• Managing Items
• Lot Management
• Inventory Overview
• Reports: 503B Control Tower
• Compliance: USP 797 & cGMP