Quality Management Software

Find the best Quality Management Software for your business. Compare product reviews and features to build your list.

Find the best Quality Management Software for your business. Compare product reviews and features to build your list.

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Rated #1 easiest and fastest QMS, CAPA, and Compliance software by Medical Device, Pharma, and Biotech companies. Hundreds of FDA, ISO, and GxP regulated companies in over 80 countries trust Qualio to bring their quality team, tools, processes, and data together in one easy to manage place. With industry experts on staff and customer service on call, we partner with you to implement strategy, prepare for audits, and convert manual processes to digital. Get a personalized demo today! Learn more about Qualio
QMS for Medical Devices, Pharma and Biotech. 100% FDA/ISO/GxP compliance. 5x faster Doc Control, Training, CAPA, NCRs, Audits and more. Learn more about Qualio

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By Arena, a PTC Business

By Arena, a PTC Business

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
Arena's product-centric QMS connects quality and product processes to simplify regulatory compliance and speed product launches. Learn more about Arena QMS

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Emerging Favorite / 2021
MasterControl Quality Excellence solutions are 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. It does this by providing cloud-based solutions that manage an organization's documents, training and exams, corrective/preventive action, validation, and more. And it's not just quality, MasterControl has solutions for the entire product lifecycle. Learn more about MasterControl Quality Excellence
Quality Management Software; includes electronic document control, training control, corrective action, audit, supplier mgmt, and more Learn more about MasterControl Quality Excellence

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Form.com specializes in taking any audit, inspection, or field data collection process and turning it into a fully integrated mobile application. Fortune 500 companies and industry leaders use Form.com applications to improve quality, promote safety, and ensure compliance in the field by streamlining operations, improving oversight, and capturing actionable insights in real time. Visit Form.com to begin your operational transformation today. Learn more about FORM.com
Form.com is an award-winning provider of forms automation solutions for the enterprise. Learn more about FORM.com

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Top Performer / 2021
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
Quality management solution that helps users manage documentation, compliance, workflows, risks, employees training and more. Learn more about Qualtrax

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With over 1 million users worldwide, Intelex Quality Management Software applications have been helping companies around the world manage, track and report their quality metrics for over 20 years. Drive continuous improvement across all aspects of your quality program, reduce risk and ensure ISO 9001 compliance with this flexible set of user-friendly applications to manage Defects, NCRs, CAPAs, Suppliers, Customers, Complaints, Audits, Training, Documents, and much more. Try It Free Now! Learn more about Quality Management Software
Trusted since 1992 with over 1.6 million users worldwide. Manage documents, audits, training, NCRs & CAPAs, ISO 9001 compliance & more. Learn more about Quality Management Software

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QT9 QMS is the only all-in-one web-based quality management solution with unlimited scalability, providing a unified platform for ISO 9001, ISO 13485, AS9100, FDA 21 CFR Part 820, Part 211, Part 11 electronic signature compliance. Empower your employees to automate: document control, CAPA's, employee training, ECR/ECN's, inspections, calibrations and audit management. Centralize your data from multiple locations & sources. Includes Customer & Supplier Web Portals. Visit QT9qms.com Learn more about QT9 QMS
QT9 QMS is the only all-in-one web-based quality management solution with unlimited scalability. Schedule a demo & start a trial. Learn more about QT9 QMS

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Rated HIGHEST User Adoption by industry leaders, ACE is an easy to use, one-stop shop, Quality Management System. With NO EXTRA CHARGE for support, additional modules or even upgrades, we can save you more money than your current provider. Offering everything from Document Management to Inspection Management, we have thousands of monthly users that trust ACE. Cloud-based software that can be personalized to your highly regulated company big or small, reach out today for a free demo! Learn more about Adaptive Compliance Engine (ACE)
Rated HIGHEST User Adoption, ACE is an industry-leading, single-platform software solution for all your quality management needs. Learn more about Adaptive Compliance Engine (ACE)

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Established Player / 2021
Intellect's QMS software is proven to enhance quality operations and reduce overall quality costs by 40%. Our apps are designed by certified quality experts and can easily be tailored with our no-code platform and drag-and-drop technology to fit your exact business needs. Give your team remote access, mobile apps, dynamic workflow, analytics and reporting with a modern and easy to use solution. Apps include Document Control, Employee Training, Audit Management, CAPA, Nonconformance, and more. Learn more about Intellect
Intellect offers a modern QMS software solution with a no-code platform that empowers everyone to innovate. Learn more about Intellect

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ETQ Reliance is the leading quality, EHS and compliance management software provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration. ETQ provides a compliance management platform that enables organizations to implement compliance processes, create new processes and automate and control their compliance ecosystem. Core solutions include Corrective Action, Risk Management, Document Control and Employee Training. Learn more about ETQ Reliance
ETQ Reliance integrates data across the enterprise to maintain regulatory compliance and mitigate risk. Learn more about ETQ Reliance

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By CAMA Software

By CAMA Software

The AFFORDABLE SOLUTION for small to mid-size companies. Designed specifically for MANUFACTURING companies, Quality Collaboration By Design (QCBD) is an integrated Quality Management Software for managing all your quality data. QCBD dramatically reduces the cost of achieving and maintaining compliance to quality management standards such as ISO 9001, ISO 13485, AS9100, TS 16949 and SQF 2000 / ISO 22000. Window-based application (client-server, not a web application) Learn more about QCBD
The AFFORDABLE SOLUTION for small to mid-size MANUFACTURING companies. Best value. full featured, QMS Software. Windows 10 (not web). Learn more about QCBD

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Emerging Favorite / 2021
#1 Quality Management Software solution. Simple for workers to use and managers to customise on any device. Fast and easy to access, enter and report risk data in real time. A platform with end-to-end functionality. Use our Out-of-the-box templates or build your own to match requirements. Try now. Learn more about Donesafe
#1 Quality Management to solve ALL your requirements. Simple for workers to use, simple for managers to customize. Try now Learn more about Donesafe

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By SafetyChain Software

By SafetyChain Software

SafetyChain Quality Manager puts busy FSQA teams in control of their yield, costs, and program compliance with a fully-integrated Quality Management Software (QMS) solution. From real-time specification verification to automated audits for regulatory, GFSI, and customer requirements, SafetyChain helps drive a completely paperless process for quality assurance and compliance. Learn more about SafetyChain
SafetyChain Quality Manager puts busy FSQA teams in control of their yield, costs, and program compliance with a fully-integrated QMS. Learn more about SafetyChain

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Greenlight Guru is the only electronic Quality Management Software (eQMS) designed by MEDICAL DEVICE PROFESSIONALS specifically to meet the unique NEEDS OF MEDICAL DEVICE COMPANIES. Our comprehensive, out-of-the-box solution is based on the latest FDA and ISO standards and best practices, all of which are meticulously woven into every feature within the cloud-based platform. Join hundreds of other medical device companies working with us to shift your focus from just compliance to True Quality. Learn more about Greenlight Guru
Greenlight Guru's eQMS allows companies to bring high-quality medical devices to market safely and quickly - reducing risks and costs. Learn more about Greenlight Guru

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The complete TURNKEY Electronic Quality Management System, ACE Essentials software, comes equipped with all the necessary Standard Operating Procedures (SOPs) so you have a FULLY COMPLIANT quality management system from day one at an UNBEATABLE price. ACE Essentials includes document management; training management; deviation, investigations and CAPA management; design control; risk management capabilities; and much more. Learn more about ACE Essentials
ACE Essentials is a preconfigured, ready-to-use quality management system for life science startups in highly regulated industries. Learn more about ACE Essentials

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By isoTracker Solutions

By isoTracker Solutions

Cloud-based QMS software that's ideal for small to medium-sized businesses, with separate modules for document control, complaints management, auditing, non-conformance management, risk and training. The software features built-in corrective and preventive action (CAPA) capabilities. Designed for easy compliance with ISO 9001 and other QM standards. Learn more about isoTracker QMS
Cost-effective cloud-based QMS software that is ideal for small to medium sized businesses. Pay only for the features you require. Learn more about isoTracker QMS

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EHS Insight is the best value in Quality Management Software available today. It has everything you need to manage quality, including nonconformance reporting, quality inspections, investigations, corrective actions, regulatory requirements and permits. Easily report and track quality incidents in compliance with company, regulatory and industry requirements, including ISO 9001. Trust the industry leader first with offline access, first with a full-suite mobile application and first in cloud. Learn more about EHS Insight
Use EHS Insight to manage quality, including nonconformance reporting, quality inspections, corrective actions, permits and more. Learn more about EHS Insight

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GoSpotCheck is a comprehensive quality management software solution powered by real-time data insights and intuitive, powerful task distribution capabilities for anyone from anywhere. Our easy-to-use mobile app streamlines tasks, inspections, audits, and QA checklists to distributed teams across the enterprise for ultimate visibility, and even works in offline mode for always-on productivity. Learn more about GoSpotCheck
GoSpotCheck is a comprehensive quality management solution powered by real-time data and intuitive, powerful task distribution. Learn more about GoSpotCheck

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Quickbase empowers organizations to proactively identify the impact of defects and continuously improve quality management by streamlining processes that run outside of core systems or are manual. Quickbase's no-code platform provides a single source of truth to monitor data from your quality processes, including customized views into performance, inspections, defects, downtime, and more. Accelerate continuous improvement by enabling your team to manage quality of materials and reduce downtime. Learn more about Quickbase
Proactively manage quality assessments and reduce downtime with Quickbase's no-code platform. Learn more about Quickbase

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--Office 365 App-- BPAQuality365 is an innovative software for integrated quality, risk and compliance to run in your secure Office 365 environment. The app runs on your preferred Microsoft tools, like Teams or SharePoint. With Teams, you have a single point of access to instant discussions, video conferencing and QMS. Frontline users and workers on the field can use the app on any device, to report incidents or lead inspections, including photos. Shift to Quality 4.0 with BPA and Office 365. Learn more about BPAQuality365
BPAQuality365 is a modern app for integrated quality to run in your Office 365 tenant, with Teams or SharePoint. Learn more about BPAQuality365

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ZenQMS is a cloud-based quality management system that is purpose-built for 21 CFR Pt.11/ Annex 11 and relevant GxP/ ISO requirements. We help tens of thousands of users to stay compliant throughout their quality journey with our easy-to-use system. Experience connected and affordable quality with our documents, training, issues (CAPAS, Deviations, and Complaints), change control and audits modules. Learn more about ZenQMS
A cloud-based quality management platform that is purpose-built for 21 CFR Pt.11/ Annex 11 and relevant GxP/ ISO requirements. Learn more about ZenQMS

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* Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more. Learn more about Qualcy QMS
Qualcy Bio-Med QMS Software for Small and Medium size Biotech, Pharma & Medical device companies to easily manage the QMS Records. Learn more about Qualcy QMS

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We support Life Science companies to improve quality management, processes, and product development through our all-in-one, pre-validated, and entirely cloud-based SaaS platform: Scilife. The Scilife platform is a versatile tool capable of managing the diverse lifecycle stages in Life Sciences companies. It's purpose-built and fully validated according to GAMP5 and 21CFR11 to comply with the rigorous demands and compliance regulations of Pharma, Biotech and Medical Device companies. Learn more about Scilife
All-in-one, pre-validated and cloud-based platform to improve quality management, processes, and product development for Life Sciences. Learn more about Scilife

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ComplianceQuest is an end-to-end Enterprise Quality and Safety Management System (QHSE = EQMS + EHS) built on the Force.com platform. Our EQMS suite offers: Audit | CAPA | Change | Complaints | Document | Equipment | Incidents | Inspection | Nonconformance/Deviations | Risk | Supplier | Training Our EHS Suite Offers: Health and Safety | Environmental | Sustainability | Contractor | Permit to Work/JSA Work.com apps: Supplier Readiness | Workplace Safety Learn more about ComplianceQuest
ComplianceQuest offers a 100% cloud based Enterprise Quality and Safety Management System (QHSE = EQMS + EHS) built on Salesforce Learn more about ComplianceQuest

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uniPoint is leading-edge Quality and Compliance Management software for the medical device, aerospace, automotive or general manufacturer. With over 40 standard integrations, we are the industry leader in ERP-Integrated Quality Management Software. uniPoint manage Non-Conformances; Corrective/Preventative Actions; Document Control; Tooling & Equipment Mgmt; Customer Service; Requests/Change Mgmt, Auditing, Education & Training; Health & Safety, Surveys, Inspections, Supplier Mgmt & Risk Mgmt. Learn more about UniPoint Quality Management Software
QMS that offers built-in quality methodologies, advanced user workflow, & eliminates manual forms & redundant data-entry. Learn more about UniPoint Quality Management Software

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What is Quality Management Software?

Quality Management software automates the process of tracking and minimizing product defects.

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