Arena QMS Description
Arena's quality management system (QMS) software, designed specifically for product-centric environments, empowers medical device manufacturers to efficiently bring safe and compliant products to the market. By integrating quality and product processes, Arena QMS simplifies the new product development and introduction (NPDI) process. It provides assurance of regulatory compliance with essential quality standards and regulations, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS improves visibility and traceability by managing quality processes in conjunction with various essential documentation, including bills of materials (BOMs), standard operating procedures (SOPs), device master records (DMRs), design history files (DHFs), specifications, drawings, and training plans. This holistic approach not only facilitates compliance but also fosters a culture of quality throughout the organization.
Arena QMS Alternatives
Epicor Connected Process Control
Epicor Connected Process Control provides a simple-to-use software solution that allows you to configure digital work instructions and enforce process control. It also ensures that operations are error-proof. Connect IoT devices to collect 100% time studies and process data, images and images at the task level. Real-time visibility and quality control on a new level! eFlex can handle any number of product variations or thousands of parts, whether you are a component-based or model-based manufacturer. Work instructions can be linked to Bill of Materials, ensuring that products are built correctly every time, even if changes are made during the process. Work instructions that are part a system that is advanced will automatically react to model and component variations and only display the right work instructions for what's currently being built at station.
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Qualio
Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness.
Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards.
Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams.
Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations.
The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.
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Digit
Digit is a software that helps companies track their operations in real-time. The cloud-based software includes features for purchasing and receiving, inventory management as well as production, sales and fulfillment.
Digit's goal is to integrate siloed system via a single operating system in order to help organizations plan and execute, measure, optimize and connect. The software offers capabilities such as creating purchase orders, serialized inventories, quality control, billing of materials and routings, sales order management and guided picking and packaging, as well integrations with QuickBooks.
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Propel
Propel is a modern, AI-powered cloud platform built for how manufacturers work today. It unifies Product Lifecycle Management (PLM), Quality Management System (QMS), and Product Information Management (PIM) into one intelligent system, giving teams a connected, always-accurate view of their products. With AI embedded across the platform through Propel One, manufacturers can automate routine work, surface insights faster, and make better decisions with confidence. AI continuously learns from product data to proactively flag risks, highlight trends, and guide next best actions across teams.
Instead of relying on spreadsheets, siloed tools, and manual handoffs, teams manage product data, changes, and quality processes in a single governed environment with full traceability. Propel creates a true digital product record that spans design, development, manufacturing, commercialization, and continuous improvement. Built-in workflows standardize change management, streamline quality events, and support compliance without slowing teams down.
Trusted by medical device, high tech, and industrial manufacturers, Propel helps organizations reduce errors, shorten cycle times, and improve collaboration across engineering, quality, operations, supply chain, and product teams. The result is faster launches, higher product quality, and a more resilient foundation for growth as products and processes become more complex.
Propel has been recognized by Deloitte as a fast-growing technology company and named to the Inc. 5000 list of fastest-growing private companies, reflecting strong customer adoption and momentum helping manufacturers modernize how they build, manage, and deliver products. Designed to scale with growing products, teams, and regulatory demands.
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Integrations
Company Details
Company:
Arena, a PTC Business
Year Founded:
2000
Headquarters:
United States
Website:
www.arenasolutions.com/platform/qms/
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Product Details
Platforms
Web-Based
Types of Training
Training Docs
Live Training (Online)
Webinars
In Person
Training Videos
Customer Support
Business Hours
Online Support
Arena QMS Features and Options
Quality Management Software
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
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