Matrix Quality

Key Features

Document Control

• Author, review, approve, and revise controlled documents with electronic signatures and full version history.
• Work on documents collaboratively rather than routing files by email.
• Pre-built templates aligned to FDA 21 CFR Part 11 and EU Annex 11 expectations.

Quality Events and CAPA

• Log deviations, non-conformances, complaints, out-of-specification results, and general quality events.
• Run root cause investigations tied to the originating event.
• Open a CAPA from an investigation, then trace it to the change control that resolves it, the SOP revision, the training assigned as a result, and the risk record affected, with full audit history.

Change Control

• Raise change requests against documents, processes, suppliers, or products.
• Route approvals through configurable workflows by change type or risk level.
• See which documents, trainings, and risk records a change touches before it is approved.

Training Management

• Assign training to individuals or by role, with due dates and escalation.
• Track completion across the organization through a training matrix.
• Build training programs that group related SOPs and courses.
• Deliver quizzes and record training effectiveness alongside completion.

Risk Management

• Maintain risk records as standalone assessments or attached to quality processes.
• Supports ISO 14971 risk workflows for device manufacturers.

Supplier, Audit, and Inspection Management

• Maintain supplier records and qualification status.
• Schedule internal audits, record findings, and track corrective actions to closure.
• Pull inspection evidence from one system rather than several.

Manufacturing and Batch Records

• Track materials, shipments, usage, and quantities.
• Maintain batch records linked to the deviations raised against them.
• Matrix Quality holds manufacturing data. It does not control equipment on the floor.

Regulatory Submissions and Trial Master File

• Manage product registrations, variations, and renewals in a central register.
• Build a TMF using configurable workflows with compliance logic built in.
• Aimed at pharma, biotech, and CRO/CDMO buyers as much as device manufacturers.

Environmental, Health, and Safety

• Investigate EHS issues and document remediation and prevention plans.

Implementation and Validation

Every deployment runs as a scoped implementation with configuration support. There is no self-serve sign-up path, which is deliberate in a validated environment but means you cannot switch it on the same day.

Timelines are measured in weeks rather than quarters. Modules ship pre-validated, which removes a large share of the testing normally required at go-live, and the Validator module supports a risk-based validation strategy with the traceability and documentation an auditor expects.

The trade-off: the platform is flexible, so process decisions have to be made during configuration. Teams that want a prescriptive out-of-the-box workflow with no choices to make will find the first few weeks heavier than expected.

Platform and Deployment

• Cloud only. Developer-hosted and browser-accessed, with no on-premises deployment option.
• No native mobile apps. Mobile access is through a responsive browser rather than iOS or Android apps.
• Data protection. Encryption in transit and at rest, with role-based access control.
• No hardware required. Nothing is sold or needed on-site.
• Language support. English is the primary interface language, with additional languages added based on customer demand. Confirm coverage for your regions before signing.

The Matrix One Platform

Connectors between Matrix Req and Matrix Quality are already deployed, giving traceability from a requirement through to the quality record it affects.

Matrix Quality Pricing

Matrix Quality publishes its licence rates, which is unusual in the eQMS market. Billing is an annual subscription priced per licence, across four licence types, so a company only pays full rate for staff who actually run quality processes.

Because cost tracks the licence mix rather than a flat per-seat rate, a company-wide rollout is cheaper here than with vendors who charge one rate for everyone. A 100-person device manufacturer running 80 Light, 15 Full, and 2 Admin licences lands around $33,600 per year. The same headcount at a flat $90 rate would run over $100,000.

Factors that affect what you pay:

• Mix of Light, Plus, Full, and Admin licences
• Number of modules deployed
• Number of sites and partner organizations
• Implementation scope, which is quoted separately from the subscription

The entry implementation package, Matrix Quality Go, covers controlled documents and training only and starts around $3,784. Broader deployments are quoted individually. The ROI calculator on the product page models your current cost of compliance against a Matrix Quality subscription, so you can size the spend before contacting sales.