Alternatives to QualityKick
Compare QualityKick alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to QualityKick in 2026. Compare features, ratings, user reviews, pricing, and more from QualityKick competitors and alternatives in order to make an informed decision for your business.
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AlisQI
AlisQI
AlisQI is a modular, cloud-based Quality Management platform for process and batch manufacturers who want to reduce firefighting, improve predictability, and stay compliant by default. Unlike traditional EQMS platforms that were built around documents and later adapted for analytics, AlisQI was designed from the start as a data-first system. Quality, lab, and production data are structured and connected in one operational backbone. That foundation now enables practical AI capabilities inside daily workflows. Manufacturers can automatically extract data from diverse supplier COAs without predefined templates, generate structured digital forms from existing files or plain language, query their QMS conversationally, and detect recurring incident patterns across sites. Core modules include Document Control, Training, Deviations, CAPA, Audits, Risk Management, Supplier Quality, SPC, and EHS, supported by targeted out-of-the-box Solvers that address specific operational problems. -
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isoTracker Quality Management
isoTracker Solutions Ltd
isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it. It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management. It can be configured to meet an organization's specific needs and provides free training and free support. It has been independently judged to provide the best customer support in its category. -
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SBS Quality Management Software
Sunday Business Systems
The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server. Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - EHS module SBS Ground Control - Employee training management (LMS) - Document control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans Great product for efficient and affordable QMS Compliance -
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Total Lean Management (TLM) Software
Lean & Mean Business Systems
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work OrdersStarting Price: $45/user/month -
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Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
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SimplerQMS
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.Starting Price: $13,750/year -
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Qualityze EQMS Suite
Qualityze
Qualityze is a leading provider of cloud-based Quality Management System (QMS) and Enterprise Quality Management Software (EQMS) solutions built natively on the Salesforce platform. Designed to streamline quality processes, ensure regulatory compliance, and drive operational excellence, Qualityze empowers organizations to manage CAPA, audits, document control, training, change management, risk management, and supplier quality within a unified, scalable ecosystem. Focused exclusively on quality and compliance, Qualityze delivers purpose-built QMS and EQMS solutions without distractions from unrelated custom development. Our platform enables organizations across life sciences, manufacturing, and other regulated industries to simplify compliance with global standards while improving visibility, traceability, and accountability. Qualityze fosters a true culture of quality by making enterprise quality management intuitive, user-friendly, and collaborative.Starting Price: $30/User/Month -
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QT9 QMS
QT9 Software
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business. Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%. With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management. Start your free trial or book a personalized demo today.Starting Price: $10,000/year -
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ARMATURE Fabric
ARMATURE
With ARMATURE Fabric™ you can manage your accreditation, certification, credentialing, audit, quality, and compliance activities within a single platform. Our software enables you to save time, operate more effectively and securely, and better serve your stakeholder communities. Whether you are managing institutional, programmatic, or specialized accreditation programs; certifying individuals, products, or organizations; conducting audits or assessments; or resolving non-conformances or other issues, ARMATURE Fabric can make it easier and more efficient for you and your stakeholders. Our secure, cloud-based software allows you to collect data in multiple ways (through online applications, audits, assessments, self-evaluations, inspections, forms, and surveys); manage your accreditation, certification, audit, and compliance workflows; capture and manage documents and artifacts, identify and remediate issues; generate reports; and spot new trends. -
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Artintech ERP
Artintech
Artintech ERP is a comprehensive enterprise resource planning solution designed to optimize and streamline your business operations across various departments. Tailored for small to medium-sized enterprises (SMEs), Artintech ERP offers robust functionality with a user-friendly interface, allowing businesses to seamlessly manage their resources, inventory, human capital, finances, and customer relations all in one integrated platform. Artintech ERP includes a wide range of modules designed to optimize business operations. Key modules include Procurement, Warehousing, CRM, Distribution, Quality Management (QMS), Workplace Safety, Document Control, Non-Conformance and Corrective and Preventive Actions (CAPA), Inspection, and Computerized Maintenance Management System (CMMS).Starting Price: $24.95/Module/Month -
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MasterControl
MasterControl
Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.Starting Price: $25,000 / 1st year -
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SoftExpert EQM
SoftExpert
SoftExpert EQM is the most comprehensive enterprise quality management software (EQMS). It helps companies to achieve and maintain ISO 9001 certification through automated, highly interactive quality processes tailored to an organization’s specific products, operations and business practices. As a modular and scalable solution platform, SoftExpert Quality Management Software seamlessly integrates all key quality initiatives, including process mapping, documented information (SOP – standard operating procedures, work instructions and records), non-conformance reports (NCR/NCMR), corrective/preventive actions (CAPA), quality indicators (KPIs). The solution also manages supplier relations, customer complaints, quality audits, competence and training, quality risks and controls, quality inspection and statistical process control, increasing QMS agility and robustness. -
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1factory Manufacturing Quality
1factory
1factory's Manufacturing Quality is a cloud-based and on-premises quality control software solution specifically created for manufacturing companies of all types and sizes. Powerful, reliable, and secure Manufacturing Quality by 1factory provides first article inspections, factory monitoring, quality control plans, in-process and final inspections, incoming inspections, inspection management, CAPAs, non-conformances, and more. Additional key features include running metrics calculations for Process Performance (Pp, Ppk), Process Capability (Cp, Cpk), variation / SPC control management, defect-risk monitoring, and more. -
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Paradigm 3
Interax Group
Paradigm 3 is a web and desktop-based platform designed to aid businesses in compliance management in regards to Document Control, CAPA Compliance, and Competency Tracking and Training. The software offers tools such as an event manager for incident investigations and customer complaints, tasks delivered by e-mail, audit preparations, among others. Some of the industries that benefit from Paradigm 3 are Healthcare, Manufacturing, Test Labs, and Service Industries. With Paradigm 3 it is no longer necessary to buy endless add on modules to manage all your compliance needs. Our system is made up of 4 modules with over 50 standard forms to meet all of your requirements for Quality, Safety and Environmental and by utilizing our form designer you can create new forms or redesign the ones supplied to ensure they exactly meet your needs.Starting Price: $1000.00/one-time -
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Grand Avenue Software
Grand Avenue Software
A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed. -
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QualityPro by TecWork
TecWork Global Business Solutions Pvt. Ltd.
QualityPro by TecWork is a modern, 𝐞𝐧𝐭𝐞𝐫𝐩𝐫𝐢𝐬𝐞-𝐠𝐫𝐚𝐝𝐞 𝐰𝐞𝐛/𝐜𝐥𝐨𝐮𝐝-𝐛𝐚𝐬𝐞𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 (𝐐𝐌𝐒) designed to help manufacturing , automotive, and regulated organizations strengthen compliance, reduce operational risk, and build a proactive quality culture. Unlike traditional systems that only store documentation, 𝐐𝐮𝐚𝐥𝐢𝐭𝐲𝐏𝐫𝐨 𝐐𝐌𝐒 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 connects quality processes into one intelligent platform—ensuring clarity, accountability, and audit readiness across the entire organization. QualityPro centralizes critical QMS workflows including: ▶ Non-Conformance & Deviation Management ▶ Corrective and Preventive Actions (CAPA) ▶ Complaint Handling & Customer Quality Events ▶ Audit Planning & Execution ▶ Calibration & Equipment Management ▶ Inspection & Quality Control ▶ Document Control ▶ Training Management & Competency Tracking ▶ Risk Management & Continuous Improvement ▶ Change ManagementStarting Price: Contact us for pricing -
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Validfor
Validfor
Validfor is a secure, modular digital validation platform that centralizes the entire validation lifecycle on a single, paperless system. Designed specifically for regulated industries, Validfor enables efficient validation while ensuring full compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The platform supports electronic records and advanced electronic signatures with full audit trails, role-based workflows (Author, Reviewer, Approver), and complete CSV compliance. All documents and records are securely managed in a centralized repository, capturing every change with full traceability to protect data integrity and Quality Assurance. Validfor offers integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, enabling seamless impact assessments, CAPA tracking, Computer Software Assurance (CSA), and audit-ready lifecycle management. -
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TrackWise
Honeywell International
Honeywell's TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to help organizations efficiently manage quality and compliance processes. Leveraging nearly three decades of industry experience, it offers integrated modules that support various quality management aspects, including document control, training management, and corrective and preventive actions (CAPA). The platform incorporates advanced digital technologies such as artificial intelligence and machine learning to provide actionable, real-time insights, enabling proactive quality management. Its flexible, modular architecture allows for seamless integration with existing enterprise systems, facilitating rapid deployment and scalability. By streamlining quality processes and ensuring compliance with industry standards, TrackWise Digital® empowers organizations to bring products to market faster while minimizing risk.Starting Price: $200 per month -
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IQE is MediaLab’s non-conforming event management system that allows clinical laboratory teams to track, assess, and prevent non-conforming events (NCE). With the capability to import or create event forms and data logs, IQE enables laboratory teams to eliminate deficiencies, correct common NCEs, and, most importantly, focus on improving healthcare. With a MediaLab institutional subscription, administrators can easily document each phase of the event management lifecycle, from initial event description to risk analysis, investigation, and root cause analysis, corrective and preventive actions plans, and overall CAPA effectiveness evaluations. IQE supports: • Customizable, pre-built event forms and workflow • Monitoring and evaluating change control events, failed PT events, customer complaints / feedback, safety / injury events, supplier / vendor issues, and more • Tracking periodic data entries • Robust reporting and dashboards to identify common NCEs and CAPA effectiveness
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TraxQM
TraxQM
TraxQM is a risk-based Quality Management System (QMS) designed to help organizations manage regulatory compliance, streamline quality processes, and improve operational efficiency through a centralized, AI-enhanced platform. It enables companies to take a proactive approach to compliance by digitizing workflows and applying structured methodologies aligned with international standards such as ISO and GxP. It includes core modules for document management, risk analysis, CAPA (Corrective and Preventive Actions), change control, audits, and training, allowing teams to manage the full lifecycle of quality operations in one system. It supports data integrity through automated version control, audit trails, and compliant electronic signatures, ensuring traceability and adherence to regulatory requirements. TraxQM leverages AI to enhance decision-making by analyzing risks, suggesting targeted control measures, and recommending relevant KPIs based on organizational objectives.Starting Price: $403.97 per month -
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Clinevo OneQMS
Clinevo
Clinevo OneQMS is a cloud-based quality management system that enables organizations to manage quality and compliance processes digitally. Clinevo OneQMS is an interactive platform to manage all quality and compliance processes of an organization. OneQMS enables organizations to manage documents, training, change, CAPA, and audits in one place. It can be accessed with basic internet/intranet using IE, Chrome, and Firefox browsers. Provides powerful and actionable dashboards and reports for real-time monitoring and tracking of quality and compliance. Business, quality, IT teams, and others can be trained on the Clinevo within a few hours. Clinevo OneQMS complies with all current and emerging regulations. It ships with an inbuilt training management system to efficiently manage the organization’s training processes. It is the best QMS software and comes with transparent optimized pricing. -
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BizPortals QCFlow
BizPortals QCFlow
BizPortals QCFlow is a comprehensive Quality Management System (QMS) software designed to help organizations manage quality, ensure regulatory compliance, and support continuous improvement. The platform provides an integrated solution for CAPA management, document control, audit management, nonconformance management, risk management, training management, inspection management, and supplier quality management. With a flexible and configurable architecture, QCFlow enables businesses in manufacturing, life sciences, healthcare, and regulated industries to automate quality workflows, improve traceability, and maintain compliance with quality standards such as ISO 9001, ISO 13485, and GMP. The system enhances visibility across quality operations, reduces manual processes, improves collaboration, and helps organizations consistently deliver high-quality, compliant products and services. -
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uniPoint Quality Management Software
uniPoint Software
uniPoint's Quality Management Software is a modular on-premise quality management software. Quality Management Software can integrate with other ERP systems with ease. Quality Management Software is suitable for manufacturers of any kind of product in any manufacturing mode. With Quality Management Software, users can manage processes such as document control, equipment management, non-conformances, corrective/prevantative actions, and more.Starting Price: $6000.00/one-time -
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QCBD
CAMA Software
Quality Collaboration By Design (QCBD) is a fully integrated quality management software solution designed specifically for manufacturing businesses. This affordable, Windows-based application reduces the cost of achieving and/or maintaining compliance with quality management standards such as ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. QCBD by CAMA Software offers a host of modules for training management, supplier management, process deviations, document control, equipment management, and more. -
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TRACKMEDIUM
Trackmedium
Cloud-based Quality Management System (QMS) software that is ideal for small to medium businesses (SMEs). TRACKMEDIUM is a monthly-based subscription service with modules including Audit Management, CAPA, Document Control, Management of Change, Nonconformance Management (NCM), and Training Management. TRACKMEDIUM enables companies to create better and safer products, improve efficiency, and achieve compliance with industry standards including ISO 9001, 14001 & OSHA while lowering costs and risks. TRACKMEDIUM's Audit Management software streamlines audit-related tasks which include creating standardized audit and checklist templates, generating an audit plan, conducting audits, identifying nonconformances and recommendations, tracking CAPAs through closure and reporting results.Starting Price: $299 per month -
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IMSXpress ISO 9001
IMSXpress
IMSXpress ISO 9001 is a document control and quality system management software. The IMSXpress client application can be installed directly on user computers, or on a Windows server and then be distributed to users by remote desktop services as a remote application. The database is an MS SQL database. It can be installed on any MS SQL Server 2014 or higher and be accessed by the IMSXpress application over any type of network. You can set up your own remote access, use our cloud-based data hosting service, or get the online subscription package. Fully automated training system with self-training, integrated document training, job descriptions, and more. Use for document, engineering, and process changes. Make fillable PDF form templates, fill the forms with data, and create records. Use for scheduling and administrating maintenance, and for managing spare parts inventory. Manage complaints, non-conformities, risk management, audit findings, and more.Starting Price: $160 per month -
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IMSXpress is a sophisticated document control, regulatory compliance, and quality system management platform used for operating ISO 13485 and FDA 21 CFR part 820 quality system that include document distribution, document control, CAPA, complaints, audits, training, MDR, supplier control, NC product, and more. Available as a local install or cloud data hosting, this cutting-edge software comes pre-loaded with template manuals and procedures, employee training booklets, and audit checklists.Starting Price: $1460.00/one-time
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Veeva Vault QMS
Veeva Industries
Ensure quality and GxP compliance with Vault QMS. With built-in best practices and automated workflows, Vault QMS brings all parties – pharma and biotech companies, contract manufacturers, and suppliers – into quality processes for better control and visibility. Easily bring departments, sites, suppliers, contract manufacturers, contract test labs, and other partners into continuous quality improvement processes. Increase operational efficiency with automated workflows and built-in best practices. Improve risk visibility across products and processes with a unified approach to risk management. Improve speed, efficiency, and GxP compliance with a unified suite of quality applications. Readily enable quality management processes with built-in best practices for deviation, internal and external audits, complaints, lab investigations, change control, CAPA, and quality risk management. -
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BIOVIA
Dassault Systèmes
BIOVIA solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the way we live. The industry-leading BIOVIA portfolio is focused on integrating the diversity of science, experimental processes and information requirements end-to-end across research, development, QA/QC and manufacturing. Capabilities over the areas of Scientific Informatics, Molecular Modeling/Simulation, Data Science, Laboratory Informatics, Formulation Design, BioPharma Quality & Compliance and Manufacturing Analytics. BIOVIA is committed to enhancing and speeding innovation, increasing productivity, improving quality and compliance, reducing costs and accelerating product development for customers in multiple industries. Manage and connect scientific innovation processes and information across the product lifecycle. -
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Sierra QMS
Sierra Labs
Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review. -
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Harrington Quality Management Software (HQMS)
Harrington Group International
HQMS' applications include Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. In business since 1991 – trustworthy source with SME Experts in Sales and Support will help with Business Case, Flexibility (on-premise or hosted, CapEx and Opex pricing models) with Support and Training & deployment planning that provides rapid learning curve with implementation guides. Secure deployment – including Single Sign On (SSO). Configuration and personalization features with customization if needed. HQMS is used cross several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.Starting Price: $500/month -
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ACE Essentials
PSC Software
Reduce risk with ACE Essentials, the pre-validated Electronic Quality Management System (EQMS) software created for all highly regulated industries. ACE Essentials comes equipped with 10 workflows built in and all the necessary Standard Operating Procedures and Policies, resulting in a fully compliant quality management system from the beginning. Understand the risks associated with your assets with ACE Essentials features including a full audit trail tracking every single action in the system. Pre-Configured Workflows. Pre-Configured Event Management (Due Dates, Scheduling and Reminders). Pre-Configured Permission-Based Security. Full Documentation Pre-Configured. 50+ Documents. Multiple Site Capability. Free Upgrades Throughout the Life of the Product. Pre-Configured Tasks List. No Validation Time. Pre-Configured In-System Notifications. Pre-Configured Email NotificationsStarting Price: $500 one-time payment -
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SolvoNext NCR CAPA
ORCA LEAN
SolvoNext – NCR CAPA is a manufacturing software designed to digitize non-conformance reporting (NCR) and corrective & preventive actions (CAPA), reducing the cost of poor quality. It streamlines documentation and collaboration for production, quality, and other teams with an easy-to-follow, four-step process that includes initiation, root cause analysis, financial tracking, and approval. The platform replaces manual, paper-driven processes with visual dashboards, automated charts, and real-time reports, eliminating human errors from spreadsheets. It also supports COPQ tracking, enabling factories to calculate and monitor the financial impact of quality issues and inefficiencies. Users benefit from built-in tools like 5 Whys and Fishbone analysis, role-based access, and automated notifications. With optional AI integration, SolvoNext provides advanced analytics, pattern recognition, and decision-making insights for smarter manufacturing operations. -
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Agatha
Agatha
Agatha offers a suite of cloud-based applications tailored to the life sciences industry, enabling centralized management of documents and processes across clinical operations, quality, regulatory, and training functions. It supports biotech, pharmaceutical, medical-device, and contract-research-organization workflows by offering modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, SOP creation and approval, Quality document management for CAPAs, deviations, and change controls, and regulatory document management. Agatha enables streamlined document creation, review, approval, storage, and sharing in one unified system, supports paperless transformation to reduce administrative burden and strengthen data security, and is built on a global-compliance architecture addressing standards like 21 CFR Part 11, GDPR, and EU Annex 11. -
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ZenQMS
ZenQMS
ZenQMS enhances the quality compliance profiles of life sciences companies via a cloud-based platform, purpose-built to manage document collaboration and control, training, issues, change management, and audits with ease. The ZenQMS team is comprised of both technology and quality leaders with the shared mission of elevating quality management to be a business imperative. -
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Almond
Almond
Almond is a professional, cloud-based, quality management software for healthcare companies. The software enables computerized management of the quality processes in compliance with regulatory requirements. The system maintains a document audit trail, and full document indexing and ultimately achieves documented evidence of all QMS processes. Manage your suppliers seamlessly through the electronic organization of certificates and agreements; all information is concentrated in one place. Assign permission to your suppliers to perform training, required by your system at their premises, using your quality system. Receive automatic email notifications before supplier certification expires. An electronic control dashboard allows you to be updated at any time on the status of the project. Create as many logbooks as you need, with no budget considerations or storage restrictions. Automatic conversion to effective after training completion. -
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IMSXpress is a cutting-edge document control and quality management system (QMS) software solution. Easy to install and intuitive, IMSXpress Quality Management improve the overall business efficiency while maintaining compliance. The solution offers a plethora of modules, such as document distribution, document control, internal audit, training, management review, Corrective/Preventive Action (CAPA), customer companies, risk management, preventative maintenance, measuring equipment, supplier control, and more.Starting Price: $790.00/one-time
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Ennov Quality Suite
Ennov
Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency -
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BabtecQ
Babtec Informationssysteme
Quality management software. We manufacture and offer QM solutions for all quality tasks – as we have done for 25 years. As quality specialists, we have developed an all-round solution for quality management with our modular software BabtecQ. In addition, we offer Babtec Qube, a cloud-based platform with which you can interconnect with your suppliers and customers to edit your quality tasks. Our products allow you to depict the whole range of quality processes, both internal and across companies – for quality you will love to share. Would you like to refresh your knowledge about quality management? Then you have come to the right place! On our knowledge pages you can find out, for example, what complaint management or 8D report are all about. The System FMEA (also termed a system analysis) is a subsection of the FMEA (Failure Mode and Effects Analysis). It is intended to investigate an entire system and check whether all of the individual components within it work together correctly. -
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Veeva Vault Training
Veeva Systems
Vault Training ensures job readiness and compliance by creating and managing role-based training requirements. Unifying document management and training, Vault Training enables life sciences companies to manage authoring, approval, assignment, and assessment of critical training materials in one place. Seamlessly manage training content with the delivery of time-sensitive assignments with a unified suite of quality applications. Easily assign training tasks based on job function or role. Track and complete training tasks or monitor status using a role-based home page. Trigger training tasks based on quality events, such as approval of relevant content changes, CAPA plans, periodic reviews, or retraining. Automate training assignments based on job functions or roles. Track, monitor, and demonstrate employee qualifications and competencies, or see training assignment status with delivered dashboards and reports, or create your own. -
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ProActive QMS
ProActive QMS
ISO and BRC compliance software meet the requirements of multiple management standards including ISO 9001, 14001, ISO 45001, ISO 27001, and the BRC standards. Intuitive powerful CAPA software, capturing continual improvement activities, non-conformities, root cause analysis, corrective and preventive actions, and top loss performance data. Effective version and change controls for system documents and controlled forms. Location issue controls for user access to role-related documents only. Compliance evaluation software listing compliance requirements, departmental/area accountability, guidance on legal and other requirements conformity for single or multiple standards including ISO 9001, ISO 14001, ISO 45001, ISO 27001, etc. Supplier, service provider, and contractor qualification, ongoing assessment, and performance enhancement made easy through customized risk work streams, assessments, software scheduled re-assessments, and targeted action logs.Starting Price: $150.95 per month -
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ExtraView
ExtraView
ExtraView is an enterprise software platform implementing business process management, global quality management systems for CAPA, adverse event reporting, food safety, bug and defect tracking, change management, customer support, helpdesk, field audit, and other workflow or issue management systems. Use out-of-the-box solutions or implement a custom requirement. Available as a service in the cloud or on your own servers. Simple to configure, yet provides a quality platform on which to implement fully validated systems such as incident management, CAPA, adverse event reporting, & root cause analysis, clinical trial data management and food safety. Implement bug-tracking, customer support, requirements management, change management and other issue-tracking systems. Many customers can take advantage of the full-featured, free, downloadable version! Learn how financial companies implement systems that regulate and control audit systems, provide corporate governance and risk management.Starting Price: $400 one-time payment -
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AssurX
AssurX
The AssurX platform is a versatile enterprise quality management system (EQMS) and regulatory compliance management platform. AssurX allows enterprises of any size or complexity to create a system that reliably communicates and coordinates quality and compliance information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. AssurX QMS software is highly configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify. -
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CAPA Manager
Adaptive Business Management Systems
Automate the identification, containment, investigation, and resolution of problems within your organization and supply chain. Trusted by thousands of users globally, this is one of the best CAPA software applications available. CAPA Manager corrective action software automates the assignment, notification, investigation, reporting, and approval of corrective actions. It error-proofs the control of the entire CAPA process, from initiation to investigation and all the way through to closure. CAPA Manager meets the requirements of all important quality management standards: 21 CFR part 11, ISO 9001, AS9100, TS 16949, and more. It keeps records of root-cause and corrective action while providing pre-defined workflows and approval gates.Starting Price: $12.49 per user/month -
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QEdge
Sarjen Systems Pvt Ltd
Sarjen’s Quality Management Software brings meaningful digital transformation to how quality is managed across regulated manufacturing environments. More than just a system to store compliance records, it uses AI to turn quality data into actionable insights. AI analyzes trends, spots early signals of deviation, and predicts potential quality risks before they impact products or processes. Automated alerts and intelligent recommendations help teams act faster, reduce manual errors, and strengthen decision-making with context-aware guidance. With machine learning, the system continuously learns from data patterns and improves accuracy over time. By combining robust quality workflows with AI-driven intelligence, the solution enhances product consistency, accelerates investigation cycles, and ensures stronger compliance. It makes quality management smarter, more proactive, and easier for your teams to adopt and trust. -
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Ennov Doc
Ennov
Unified Access to All Documents - Consolidates documents & processes in a unified document repository that can be used for Quality, Regulatory, R&D and more. - Metadata-based document model to adapt to your company’s organizational needs. - Configurable without any IT skills. - Scalable & secure: manage large volumes of documents. Improved Productivity and Efficiency - Intuitive user interface - Efficient search capabilities - User-centric design and connectivity to Microsoft Office 365 and Google Drive - PDF viewer to allow instant access to documents without MS Office or Acrobat - Versioning - Complete document cycle management Supports wide EDM needs - Quality, regulatory, cR&D, legal, commercial - CFR21 part 11 compliant - Document archival included - Seamless integration with Ennov Process (BPMS) & Dossier (eCTD publishing) - Advanced live reporting and dashboarding - Configurable without IT skills (including dashboards) - Suitable for regulated industries -
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DHC VISION
DHC Business Solutions
We offer solutions for companies with a high demand for quality. Our software solutions inspire with a modern UX, useful functionality, high modularity, and consistent compliance. Integrated solutions for quality management and quality assurance. Focused on the digitization of controlled documents and QA processes. Solutions specifically designed to meet the needs of the financial industry for the written rules of procedure, management of policies, and the control of information security. The cloud-based, pre-validated solution to automate your validation processes and to digitally control and manage validation documents. Early set-up of a digital QMS with a dedicated solution for startups and young companies. Based on DHC VISION. It can be used out of the box with immediate compliance and no license costs. Together, we digitize quality management and quality assurance processes and ensure regulatory compliance. -
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LabWay-LIMS
Ambidata
With LabWay-LIMS dedicate yourself to what you know how to do best and manage your laboratory. Integrated digital solutions for the organization and management of laboratory information. With the main objective of promoting productivity increases and process quality improvement, and oriented to any reality, LabWay-LIMS allows to computation of all areas of the laboratory. LabWay-LIMS is a highly competitive LIMS and QMS solution for different areas of activity. Proactive communication system and control of records of pending activities and processes. Integrated document management, quick and easy to use, providing verification and evaluation of orders and purchases. Management of internal and external audits for continuous improvement. Efficient team management, offering both profitability and speed. We align quality with management strategy. Management of immediate actions and effective resource management. Speed in sending results and improvement in service quality. -
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Metaware QMS Platform
Metaware
Metaware.nl is a modern, scalable quality management software platform that helps organizations implement, manage and continuously improve their Quality Management System (QMS or GRC). The platform fully supports ISO 9001, ISO 14001, ISO 27001 and other international standards, enabling organizations to demonstrably comply with laws, regulations and certification requirements. Metaware centralizes document control, process management, risk management, incident and complaint management, CAPA, internal audits and management reviews in one secure, cloud-based sovereign solution. With real-time dashboards, workflow automation, role-based access and version control, organizations gain full control over quality, compliance and operational performance. Metaware reduces administrative burden, increases transparency and supports continuous improvement, making it suitable for both SMEs and enterprise-level organizations focused on professional quality assurance and compliance management.Starting Price: €142/month (Bronze) -
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Orcanos ALM and QMS
Orcanos
Deliver products on time and on budget with Orcanos, an integrated software for ALM (Design Control) and quality management (QMS). An affordable cloud solution, Orcanos supports Requirements Management, Test Management, Document Control, Risk Management, and Quality Management procedures, on a single repository. Orcanos also features dashboards and real-time alerts, to help businesses keep track on their ongoing projects and gain real-time visibity on their progress. Orcanos e-DMS is an all-in-one document control software system that has been designed to allow end users to create, trace, search, archive and approve all documentation that is related to every stage of a medical device product launch. The e-DMS ensures that documents relating to the planning, design, development, manufacturing and service of a particular product can be quickly accessed, increasing the effectiveness of quality processes and reducing the time to market.Starting Price: $69.00/month/user
