Quality Management Software

Qualio is a cloud-based quality management software system designed for life science companies. Qualio empowers medical device, pharmaceutical, biotech and contract organizations to get to market faster, boost revenue and cut risk. Over 500 companies in 80 countries use Qualio to embed and automate GxP, FDA and ISO compliance. Qualio unites your teams, processes and data in a single source of truth that supports a culture of quality and makes your business stronger, fitter and more competitive. Learn more about Qualio

ETQ is the world's most flexible, powerful & easy-to-use advanced QMS software for quality-centric organizations in dozens of industries. Automate & standardize all aspects of quality, from doc control, training, CAPA, audits, supply chain & so much more. Use applications out-of-the-box or customize to meet your needs. Keep pace with regulations & increased consumer demands. Benefit from improved compliance, enhanced reputation, reduced costs, speed to market & visibility into your supply chain. Learn more about ETQ Reliance

1factory provides easy-to-use yet powerful Manufacturing and Supply Chain Quality Control software. Manufacturers can control product quality both within their factories, and across their supply chains. Features include Automatic Drawing Ballooning, QC plans, FAI, AS9102, Automated CMM data Import, Incoming/in-process/Final inspections, SPC, Process Capability (Cpk, Ppk), E-Sig, Validated Software, ITAR, Gage Calibration, NCR, SCAR, CAPA, Audit Findings, PPAP, PFMEA, Supplier Collaboration. Learn more about 1factory

MasterControl - Quality Excellence helps you automate your quality processes to dramatically improve efficiency, ensure compliance and accelerate time to market. Being used by five of the largest regulatory agencies in the United States. A leading software-as-a-service (SaaS) provider, MasterControl helps companies get their life-improving products to market sooner. And it's not just quality, MasterControl has solutions for the entire product lifecycle. Learn more about MasterControl Quality Excellence

Qualtrax is a complete quality and compliance software system used to manage and control documentation, automate business processes, manage customizable workflows, streamline training management, manage internal and external audits and ensure implementation of critical industry regulations in real-time. Ideal for heavily-regulated industries, where compliance with standards including ISO 17025, 17020, 13485, and 9001, TNI, GFSI, FDA, and FQS are required. Learn more about Qualtrax

Arena's product-centric quality management system (QMS) streamlines new product development and introduction (NPDI) by connecting quality and product processes. Arena ensures regulatory compliance to quality standards and regulations including FDA 21 CFR Part 820, Part 11 and ISO 13485. Arena QMS enhances visibility and traceability by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans. See ArenaSolutions.com. Learn more about Arena QMS

Unifize is a unique QMS with integral seamless collaboration at the heart to unblock and accelerate any workflow from NCs to CAPAs, audits and beyond while maintaining your compliance with ISO, SQF, ITAR and other standards. Easily configured and scalable, powered by an intuitive no-code platform, multi-level approvals, document control & versioning, and integrated training management ensuring your team delivers and leverages effortless internal or external (e.g. vendor/customer) collaboration. Learn more about Unifize

SafetyChain is the #1 Plant Management Platform purpose-built to improve yield, maximize productivity, and ensure compliance standards. Quality Management Software gives operators and managers control over their programs by making safety and quality data instantly accessible from any device. Achieve ongoing compliance with regulatory, customer, and third-party certification (ISO, SQF, BRC, FSSC-22000, HACCP, and more) requirements with SafetyChain. Learn more about SafetyChain

Enhance quality operations and reduce overall quality costs by at least 40% with Intellect QMS. - Easy to use - Fast to implement - Highly flexible with a no-code compliance platform - Best-in-class customer support Intellect is designed for organizations with 100 employees or more as well as startups with funding. Achieve compliance, improve audit metrics, throughput, resolution time, lower cost of quality, and reduce risk, returns, defects and much more. Learn more about Intellect

Greenlight Guru is the only quality management platform designed specifically for medical device companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more. Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality Learn more about Greenlight Guru