SUPPLIER MANAGEMENT QUALITY SOFTWARE

Supplier controls built for medical device quality teams

Qualify, classify, and review every supplier in one validated system, with supplier documentation, audits, and quality events linked to the records that depend on them.

Trusted by 1000+ medical device companies

Tracking suppliers on spreadsheets
won't hold up under inspection

Supplier qualification is one of the most common sources of FDA 483 observations. Greenlight Guru
helps keep your supplier controls organized, compliant, and audit-ready at all times.

Audit-ready by default

Pull up supplier files, certifications, and quality events in the format inspectors expect.

Risk informs supplier controls

Add risk levels to suppliers to help inform your documentation, monitoring, and audit schedule.

One connected system

Suppliers link to the parts they provide and the quality events they touch

Manage supplier quality without leaving your QMS

Supplier qualification, risk-based monitoring, and quality events run in the same system as your documents, audits, and nonconformances.

Approved supplier list with risk classification

Classify once, then let the matrix guide the work

Use custom fields to add risk levels, criticality flags, and the supplier type and goods or services they provide.

Set risk levels that fit your procedure

Risk levels aren't prebuilt. Define the levels that match your Supplier Management Procedure, then map each one to the auditing, monitoring, and documents it calls for.

Let the Supplier Policy Matrix prompt the right steps

The matrix suggests required documents and flags whether auditing or monitoring is needed for each risk and type combination, guiding your team through a consistent process as records are created and managed.

Centralized supplier documentation linked to your QMS

Every certificate, agreement, and questionnaire lives with
the supplier

Store quality agreements, ISO 13485 certifications, SOC 2 reports, and other supplier documents against the supplier record, and bulk-associate controlled documents to suppliers from your document library.

Bring suppliers in without manual entry

Import your supplier list from a CSV or XLSX file, mapping built-in fields and any custom fields you've configured, so onboarding a full supplier base doesn't mean typing one record at a time.

Keep the list current as suppliers change

Add custom fields for the data your procedure tracks, reorder them to match how your team works, and obsolete suppliers you no longer use with a recorded reason, with the option to bring them back if that changes.

Reminders for the dates that matter

Never let a supplier qualification quietly lapse

Set reminders on a supplier for expiring certifications, upcoming audits, or periodic reviews, each with a title, description, and due date, so the next action is always clear.

Keep reviews moving as the list grows

Reminders live on the supplier record itself, so the work stays visible whether you're managing three suppliers or three hundred.

Suppliers connected to quality events

Establish a bi-directional link to quality events

Associate a supplier with a nonconformance, audit, or customer feedback event and the link works in both directions. Open the supplier from the event, or the event from the supplier, and edit from either workspace.

Answer the audit question directly

When an inspector tests whether your supplier controls are real, you can move from a supplier to the nonconformances, audits, and feedback tied to it, and back again, without rebuilding the story from separate files.

Supplier management is part of a
complete medical device QMS

Supplier controls bring supplier documentation, approvals, auditing, and monitoring into one place, so teams can maintain clearer records and stay better prepared for audits.

Document Management		Risk Management
Quality Events / CAPA		Supplier Management
Audit Management		Training Management

"The biggest reason we chose Greenlight Guru was that their eQMS was designed for device manufacturers and developers. It is very specific to
our needs.”"

Laura Vitale, Vice President of Quality, MediBeacon

Frequently asked questions

How does Greenlight Guru handle supplier risk classification?

When you add a supplier, you set a risk level that informs documentation, auditing, and monitoring requirements, helping create a consistent process for applying supplier controls.

Can we run Supplier Corrective Action Requests inside Greenlight Guru?

Yes. Greenlight Guru supports flexible, approval-based Quality Events workflows that can be used for SCARs. You associate the supplier with the event, and the link is visible and editable from both the event and the supplier.

What does the FDA expect from supplier controls under the Quality Management System Regulation (QMSR)?

Under 21 CFR Part 820, harmonized with ISO 13485:2016, manufacturers must evaluate and select suppliers based on their ability to meet specified requirements, define the type and extent of control based on supplier and product risk, and maintain records of acceptable suppliers. Inspectors will ask for those records and expect to trace them to specific devices.

How is supplier quality management different from a vendor management tool?

Vendor management tools track contracts, spend, and procurement metrics. Medical device supplier management software tracks the regulated obligations: qualification, risk classification, periodic review, quality agreements, and the links between suppliers and the quality records that depend on them.

Can we use this if we only have a few suppliers right now?

Yes. Pre-market and early-stage teams use Greenlight Guru to set supplier controls correctly from the start, so adding suppliers later doesn't require retroactive cleanup before a submission or first audit.

See supplier controls that hold up under inspection

Greenlight Guru gives medical device quality teams one validated system for supplier qualification, risk-based monitoring, and the documentation and quality records that depend on it.

QMSR is here! Is your quality system ready?

SUPPLIER MANAGEMENT QUALITY SOFTWARE

Supplier controls built for medical device quality teams

Trusted by 1000+ medical device companies