What Is QMS?

QMS Software
Ensures Compliance

WHAT IS A QUALITY MANAGEMENT SYSTEM?

A quality management system (QMS) provides a formalized system to document policies, processes, and procedures to meet strict mandatory FDA regulations, ISO standards, and other directives. For regulated companies, QMS solutions ensure the ability to design and deliver products that are safe and effective.

WHY YOU NEED QMS

QMS Video

The FDA mandates that medical device, biotechnology, and other life sciences companies must establish and follow quality systems to ensure their products consistently meet applicable requirements and specifications.

Even non-FDA regulated industries need QMS to address ISO, OSHA, SOC, SOX, and other regulations or standards. Quality management systems help eliminate nonconformance issues, reduce audit risks, and improve new product development processes.

THE KEY ELEMENTS OF QMS

  • ​Ensuring regulatory compliance
  • Helping establish strong design controls
  • Providing closed-loop CAPA processes
  • Improving training record management
  • Managing design history files (DHFs)
  • Documenting device master records (DMRs)
  • Connecting product and change process
  • Driving faster product development and launches
  • Eliminating audit risks
  • Managing SOPs, policies, and other documentation
  • Enhancing supplier management and collaboration
  • Improving visibility, traceability, and business insights

What Is QMS Software?

Closed-Loop Quality Management Diagram

Quality management software is an automated application that assists with the development, maintenance, and implementation of a quality management system. While the FDA and other regulatory bodies do not require medical device companies to use software to manage their quality systems—QMS software introduces significant controls and eliminates confusion and errors caused by paper-based, manual, or disconnected systems.

Cloud-based QMS software offers the easiest way to deploy, validate, and drive closed-loop quality management processes—reducing  your compliance and audit risks.

How Arena QMS Software Helps

Arena Quality Management System (QMS) software connects your quality records to the entire product record and bill of materials (BOM). With a single source or truth, you can document and track closed-loop quality processes for device master records (DMRs), design history files (DHFs), training records, and corrective and preventive actions (CAPAs) in context to product design.

Safe Products Icon

CREATE SAFE PRODUCTS

  • Fosters continuous improvement with traceable quality processes
  • Improves control and visibility by managing quality processes from concept through commercialization
Single QMS System Icon

USE A SINGLE QMS SYSTEM

  • Uses a single QMS solution connected to the product record, BOM, AML, AVL, and changes
  • Manages critical quality documents including SOPs, DMRs, DHFs, and CAPAs
PLM Compliance Icon

ENSURE REGULATORY COMPLIANCE

  • Ensures everyone is trained with proven competence
  • Unifies your quality management process to reduce FDA, ISO, and other audit or compliance risks

Why Product-Centric
QMS is Better

When a Quality Management System (QMS) is connected to product processes, it eliminates disconnected silos that lead to quality issues, manufacturing mistakes, and audit risks. Arena’s cloud-based QMS helps quality, engineering, operations, and suppliers collaborate in real time—enhancing visibility and traceability.

HOW ARENA QMS MEETS YOUR TEAM GOALS

Arena Solutions helps everyone work together and provides significant value for these teams:

ARENA QMS IS PROVEN

Arena Quality Management System delivers quality excellence and drives successful product launches. If you need to comply with FDA regulations (21 CFR Parts 11, 820), meet ISO quality standards (ISO 13485, ISO 14971, ISO 9000), or adhere to other regulatory directives, it’s time to see why Arena’s cloud-based QMS is the choice for MedTech companies.

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