Your product is only as compliant as your supply chain. Affinity QMS Supplier Management maintains your Approved Vendor List, manages supplier qualification workflows, tracks incoming material inspections, and schedules annual re-qualifications — keeping your supply chain compliant across all six regulated industries.
Approved Vendor List — Supplier Status
Supplier status is automatically updated based on qualification results, audit scores, and re-qualification outcomes. Purchasing is blocked for disapproved suppliers at the system level.
Approved Vendor List (AVL) with Status Tracking
Maintain a centralized Approved Vendor List with supplier status — Approved, Conditional, Disapproved, or Under Review — for every raw material, component, and service provider. Status is visible to procurement, quality, and operations in real time. Disapproved suppliers are flagged at the purchasing stage — preventing unauthorized supplier use before it becomes an audit finding.
Supplier Qualification Workflow and Scoring
Define qualification criteria for each supplier category — questionnaires, audit requirements, certifications, sample testing. Qualification workflows route through required approvals and generate a supplier qualification score. New suppliers are not added to the AVL until qualification is complete and approved — satisfying 21 CFR Part 820.50 and ISO 13485 Clause 7.4 requirements.
Incoming Material Inspection Records
Document incoming material inspections for every received shipment — with lot number, quantity, inspection criteria, test results, accept/reject decision, and inspector identity. Inspection records are linked to the receiving lot and to the supplier's AVL record. Failed incoming inspections automatically generate a supplier NCR in the Deviations module.
Certificate of Analysis (COA) Management
Attach, review, and archive Certificates of Analysis for every incoming material lot. COA review — comparing supplier-stated specifications against your acceptance criteria — is documented within the incoming inspection record. COAs are retrievable by lot number at any time — critical for batch record review, product recall investigations, and FDA inspections.
Supplier Audit Scheduling and Records
Schedule periodic supplier audits based on supplier risk level and regulatory requirements. Supplier audit checklists are pre-built for each vertical — covering quality system documentation, production controls, regulatory compliance, and corrective action capabilities. Audit scores update the supplier's AVL qualification status and feed into re-qualification decisions.
Supplier Deviation and CAPA Linkage
When a supplier provides nonconforming material or fails to meet quality requirements, a supplier deviation is generated and linked to the supplier's AVL record. Deviations requiring corrective action generate a CAPA assigned to the supplier relationship owner — with tracking of supplier response, timeline, and effectiveness. The supplier's deviation history informs re-qualification decisions.
Annual Re-Qualification Scheduling
Set annual re-qualification intervals for each supplier based on risk level — critical suppliers annually, standard suppliers every 2-3 years. Affinity QMS tracks re-qualification due dates and sends automated reminders to supplier quality owners. Suppliers past their re-qualification date are flagged on the compliance dashboard — and their AVL status automatically set to Under Review.
| Regulation / Standard | Clause / Section | Supplier Management Coverage |
|---|---|---|
| 21 CFR Part 820.50 | Purchasing Controls | Supplier evaluation, selection, qualification, purchasing data, verification of purchased product |
| ISO 13485:2016 | Clause 7.4 — Purchasing | Supplier evaluation criteria, purchasing information, verification of purchased product |
| 21 CFR Part 211.84 | Testing and Approval or Rejection | Incoming material testing, COA review, lot acceptance/rejection documentation |
| 21 CFR Part 111.70–77 | Supplier Qualification — Dietary Supplements | Approved supplier list, identity testing, COA verification, supplier qualification records |
| SQF Code | 2.7 — Supplier and Raw Material Management | Approved supplier program, incoming material inspection, supplier monitoring and review |
| FSMA / 21 CFR Part 117 | Supply Chain Program | Supplier verification activities, hazard analysis for supplier controls, documentation |
| FDA QMSR (2024) | 820.50 — Purchasing Controls | Supplier qualification, purchasing data requirements, incoming inspection verification |
Included in QMS Core — Starting at
$299/mo
Supplier Management is included in the base QMS Core tier ($299/mo) and all tiers above it. AVL, qualification workflows, incoming inspection records, and COA management are included — no additional cost.
Book a demo and see how Affinity QMS Supplier Management maintains your AVL, qualification records, and incoming inspection documentation — across all six regulated industries.