Your FDA audit is only as strong as your supplier documentation.

Clover provides a structured supplier qualification system where you define your requirements (ISO certifications, quality agreements, supplier questionnaires) and suppliers complete them through a guided portal with real-time validation. Every document is versioned, every approval carries context, and the qualification record builds itself as your team works. Deployed in weeks without custom development.

Clover automatically records the full decision trace for every supplier interaction: what was submitted, who reviewed it, what exceptions were noted, and why it was accepted. FDA expects you to demonstrate that documents were evaluated against your requirements by qualified personnel with documented rationale. Clover builds that record continuously, so audit prep becomes a matter of pulling the record, not reconstructing it.

Supplier qualification falls under your quality system per 21 CFR 820.50 (purchasing controls), and the records Clover holds (reviews, approvals, and signed quality agreements) can be pulled directly into an FDA inspection. Every action is attributable to a named user, time-stamped, and captured in a tamper-evident, exportable audit trail, with role-based access controls and electronic signatures on agreements. These are the electronic-record and signature controls that support a 21 CFR Part 11 program; formal system validation (CSV) and your SOPs remain with you, and our team works through your validation and security review as part of the evaluation.

Clover tracks every compliance document with its expiry date and automatically triggers renewal workflows before certifications lapse. When an ISO 13485 certificate or quality agreement is approaching expiry, your team gets a task, not a surprise during audit prep. The system maintains a complete version history so you can demonstrate continuous compliance, not just point-in-time snapshots.

Clover lets you configure re-qualification as a recurring workflow: define the criteria, required documents, approval routing, and review cadence. When re-qualification is due, Clover automatically initiates the process with the supplier, collects updated documentation, and routes it through your approval chain. The re-qualification record links back to the original qualification, giving you a complete supplier history.

Clover structures supplier change notifications as a formal workflow rather than relying on email promises. When a supplier needs to report a material or process change, they submit it through Clover with supporting documentation. Your quality team reviews it, documents the impact assessment, and either approves, rejects, or initiates a re-qualification, all with a complete audit trail attached to the supplier record.

Clover is a configurable platform deployed in weeks, not a custom-built QMS that takes months of IT resources. You define your qualification workflows, document requirements, and approval routing through configuration. Clover handles the supplier-facing portal, document collection, validation, and audit trail. Most medical device companies are running live supplier workflows within 3 to 4 weeks of starting setup.

Clover structures the entire SCAR process as a workflow: from issue identification through supplier response, root cause analysis, corrective action plan, and effectiveness verification. Every step is documented with timestamps, responsible parties, and supporting evidence. The corrective action record links to the supplier's qualification file, giving your quality team a complete picture of supplier performance over time.