Quality
Management
System Package

Arena QMS Ensures Compliant
Product Development

QMS SUPPORTS CONNECTED QUALITY MANAGEMENT

With Arena’s quality management system (QMS), you start with establishing compliant processes, then drive to market advantage for all your design control processes from development to FDA 510(k) clearance, full approval, and production.

ARENA QMS LAUNCH

Single source of product truth and quality management

Product Record Control—DMR
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Quality Management—DHF, CAPA, CAR, ISO Support
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Document Management
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Change Management
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Regulatory & Compliance
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Collaboration
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Supplier Quality Management
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Project Management
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Design Requirements Management
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Issue and Complaint Management
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Business Insights
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3D Visualization
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Training Management
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Security Controls
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Arena Validate
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Information Sharing
API, Import, Export, Data Extract, Supplier Item Lookup w/Octopart
Integration Products
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Automations
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Onshape CAD Connection
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Infrastructure
Unlimited Storage**
8 Workspaces

$ 3D Visualization – Additional fees apply.
$ Training Management – One license included for every Write Read or Read Only license purchased. Additional licenses available for a fee for corporate-wide training needs.
$ Arena Validate – Additional fees apply.$ Integration Products – Additional fees apply. For more complex customer needs, Arena also provides MCAD, EDA, ERP, and other enterprise integration solutions.
$ Automations – includes 5 Automations. Each additional 5 Automations is available for a fee. Subject to Arena’s Fair Use Policy.
** Subject to Arena’s Fair Use Policy.

LICENSING FOR YOUR TEAM

Purchase the right licenses for everyone on your team, including partners and suppliers.

LICENSE OPTIONS

TEAM

Write Read

Empower teams to collaborate on all things

VPs, CTO, Engineering, Ops, QA, Engineers, Document Management, Sourcing & Procurement

Read Only

Everyone should know what’s going on

CEO, SVPs, Manufacturing, Purchasing

Supplier

Easily have partners participate in the product processes

Supplier Mechanical Engineer, Electrical Engineer, Manager, Sales Rep.

Training

Increase effectiveness and ensure compliance across teams company-wide

All Team Members With Training Compliance Requirements; e.g., Engineering, Quality, Operations, Field Service, Customer Service

DESIGNED TO MEET YOUR EVOLVING NEEDS

Arena’s cloud platform scales with your business requirements.

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PROVEN SCALABILITY

Bring dispersed teams, processes, and product information together in a single system.

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ROLE-BASED ACCESS

Give your teams secure, appropriate-level access coupled with critical audit history tracking.

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COLLABORATION

Provide multiple avenues for formal and informal collaboration—all secure, all auditable.

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BUSINESS-READY INTEGRATIONS

Explore our enterprise integrations for CAD, ERP, CRM, and more.

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BUSINESS INSIGHTS

Uncover gaps and opportunities in product processes with advanced reports and analytics.

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SECURITY

Address every layer of security to protect your proprietary information.

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CLOUD INFRASTRUCTURE

Benefit from secure, multi-tenant cloud architecture to maximize performance.

DOWNLOAD QMS SOLUTIONS BRIEF

See how Arena QMS ensures product development and compliance.

DOWNLOAD

Designed to Simplify Compliance

Subject to FDA regulations and ISO standards? Arena Quality Management System software enables design controls compliance, supports fast validation, and provides a simple path to stay current with new releases.

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AUDIT TRAIL

Arena QMS creates a persistent, automatic history of your product and quality records, including revisions, document versions, approval results (including 21 CFR Part 11 requirements), and actions.

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SECURITY

Arena’s multilayered, robust security model ensures you exceed FDA and ISO requirements. As a best-in-business cloud solution, Arena provides much of the security framework you need across application, physical, and process layers.

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VALIDATION

We embed compliance in our software development process and deliver Arena Validate, a comprehensive validation documentation set for use as objective evidence for your accelerated validation.

WITH OVER 1,400 GLOBAL CUSTOMERS,
YOU'RE IN GOOD COMPANY

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