Quality Management System (QMS)

An all-in-one cloud QMS solution that unites compliance, quality, validation, training records, and document management.


What is QMS?

A quality management system (QMS) is a formalized system that documents policies, processes and procedures to enable companies to meet strict mandatory FDA regulations and compliance standards for ISO, OSHA, SOC and SOX. QMS aims to eliminate nonconformance to specified standards, reduce quality risks, accelerate audit approval and improve product development processes.

Learn the Importance of QMS

What is Quality Management Software

Quality management software is an automated application or toolset that assists with the development,
maintenance, and implementation of a quality management system. Quality management software can be built and maintained internally or can
be managed by third parties. Cloud-based software as a service (SaaS) saves on
costly internal development and maintenance costs, and easily extends to stakeholders at every
level the ability to view, report, and collaborate on the standards they are to meet, from anywhere in the world.

Why Arena Quality Management?

Arena provides an all-in-one product development platform with embedded QMS capabilities to answer the rigors of compliance, avoid costly mistakes and maximize your competitive advantage. Our product-centric approach to QMS ensures your entire cross-functional team, including supply chain partners, can see quality actions, participate in resolving product quality issues quickly and see the quality history.

Benefits of Product-Centric QMS

In today’s competitive global market, mandatory compliance has become ever more rigorous. The strict requirements of FDA regulations, ISO quality standards, OSHA, SOC and SOX place burdens companies must meet. Disparate spreadsheet and document-centric QMS systems are disconnected from the product record and increase issues associated with managing closed-loop CAPA quality processes.

Quality Management Software helps adhere to cGMPs

Arena’s product-centric QMS approach provides additional benefits to high-tech, medical device, and other companies that must adhere to current good manufacturing practices (cGMPs) with products that include electrical, mechanical and software components.

Arena’s quality management software takes a bill of materials (BOM) based approach to quality management enabling companies of all sizes to optimize quality management in the context of managing the entire product record. With Arena, BOMs link to CAPA, engineering changes and other product-driven processes. In this way, Arena maintains easily audited electronic Device Master Records (DMRs) and Design History Files (DHFs).

Reduce oversights and missteps with a Quality Management System

When a Quality Management System (QMS) is closely tied to a product lifecycle management (PLM) system, supply chain oversights, employee missteps and product design errors can be reduced.

The Advantage of Cloud QMS

Arena’s platform is designed to ensure maximum usability and scalability. Start-ups to Fortune 500 companies and their supply chain partners rely on Arena to manage their quality processes, accelerate product development and safeguard their intellectual property. Internal and external teams can immediately use Arena without cumbersome configuration or training exercises. Accessing Arena from any browser anytime around the world is easy.

What Are the Essential Components of QMS?

Arena’s comprehensive quality management software provides the organizational structure, policies, procedures, business processes, solutions and other resources needed to implement a superior quality management system.

  • Internal Audit Planning & Reporting
  • Visibility into CAPA
  • Change Management
  • Access to Design History Files (DHFs)
  • Access to Device Master Records (DMRs)
  • Document Management
  • Ensures Environmental Compliance
  • Non-Conforming Materials Reporting
  • Access to Product Definition
  • Visibility throughout the entire product realization process
  • Total Project Management
  • Standard Operation Procedures (SOPs)
  • Supplier Quality Management
  • Analytics & Reporting
  • Supply Chain Collaboration
  • Complete Control & Access to Training Records

 

  • Customer Success Demonstrated
  • Customer Community
  • Supply Chain Partner Adoption
  • Customer Support
  • Customer Support Team
  • Implementation Services
  • Implementation Team
  • Industry Customer References
  • 1,300+ Companies in 80+ Countries
  • 1,500+ Partners
  • Included
  • Dedicated Internal Team
  • Documented + Proven Fixed Price Methodology
  • Dedicated Internal Team
  • Yes, Ask Us for References!
  • Document-Centric QMS Vendors
  • Ask
  • No
  • Ask
  • Ask
  • Ask + Time & Materials
  • Often Sourced
  • Ask

Arena QMS gives companies a way to guarantee quality excellence and maximum business results. Why do hundreds of innovative businesses around the world rely on our quality management software? Because it’s tough to meet compliance with increasingly stringent FDA regulations (21 CFR Parts 11, 210-211, 820, 606) and meet complicated ISO quality standards (ISO 9000, ISO 13485, ISO 14000, ISO/TS16949).