Alternatives to QMS Manager PRO
Compare QMS Manager PRO alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to QMS Manager PRO in 2026. Compare features, ratings, user reviews, pricing, and more from QMS Manager PRO competitors and alternatives in order to make an informed decision for your business.
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Interfacing Integrated Management System (IMS)
Interfacing Technologies Corporation
Interfacing’s Integrated Management System (IMS) is an AI-powered platform that unifies BPM, QMS, Document Control, and GRC into one platform. Organizations use IMS to model and automate processes, control documents, manage risks, and maintain regulatory compliance with full traceability and audit readiness. Built for highly regulated sectors such as aerospace, life sciences, finance, and government, IMS provides real-time visibility, automated workflows, and AI-driven insights that improve quality and reduce operational risk. The platform is ISO 27001 certified and fully validated for 21 CFR Part 11, making it suitable for mission-critical environments requiring strong governance, security, and control. IMS also includes low-code automation, process mining, audit management, training tracking, CAPA workflows, and dashboards to help teams streamline operations and continuously improve. AI strengthens governance, improves accuracy, and reinforces regulatory control. -
2
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
Affordable QMS Software for Small and Midsize Organizations The SBS QMS Suite is an integrated Quality Management System (QMS) software solution designed to help small and midsize manufacturers and other quality-driven organizations efficiently manage ISO 9001 and related quality requirements. Five specialized modules provide document control, employee training, CAPA and nonconformance management, audits, risk management, calibration, preventive maintenance, supplier management, inspection and SPC. SBS QMS Software is available as a cloud-based or locally installed solution and uses flexible concurrent-user licensing. Organizations may implement the complete QMS Suite or purchase individual modules to fit their quality system requirements and budget. Professional QMS capabilities without the enterprise price tag. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - Environmental Health and Safety (EHS) module SBS Ground Control - Employee training management (LMS) - Document control - Change 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 For a small or midsize manufacturer seeking ISO 9001 QMS functionality without enterprise-level cost and complexity, SBS QMS Suite is an option worth considering. -
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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 -
5
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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Sunday Business Systems
Sunday Business Systems
Sunday Business Systems (SBS) offers comprehensive quality management software (QMS) and consulting services to improve compliance with quality management standards, including ISO 9001, AS9100, ISO 14001, ISO 45001, and ISO 13485. Our solutions, such as Corrective Action and Preventive Action (CAPA) management, document control, and employee training management, help businesses streamline operations while ensuring compliance with industry regulations. SBS provides software tools for a full rangce of systems including audit management, calibration control, Preventive maintenance, EHS tracking, vendor management and inspection data collection and statistical process control (SPC). SBS provides on-premise and cloud-based solutions and customized software tailored to the unique needs of small businesses, improving productivity and operational efficiency. SBS offers the best value in QMS software.Starting Price: $295 -
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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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BPAQuality365
BPA Solutions
BPAQuality365 is a prebuilt QMS software to use in your secured Microsoft 365 cloud, leveraging tools used by collaborators daily, with no need to change user habits. It’s modern, compliant with any device, flexible to match your unique needs, and powered by innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, risk, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app is closely integrated to discussion flows in Teams and enable instant quality improvement. Go a step further and reach your Quality 4.0 objectives by combining powerful AI features, best-in-class workflow automation, business intelligence and mobile Power Apps to run on any device. Benefit from BPA’s Microsoft Preferred status to configure your QMS to your needs, transfer knowledge to your power users and get trained on M365 technologies. -
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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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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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Qualcy QMS
Qualcy Systems
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.Starting Price: $799 per month -
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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. -
13
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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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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ZenQMS
ZenQMS
ZenQMS is an AI-enabled electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO companies. The cloud-based, fully validated platform supports document control, training management, audits, supplier management, CAPA management, quality data intelligence, and compliance with FDA 21 CFR Part 11 and ISO standards. Unlike legacy systems, ZenQMS is designed for companies of all sizes to be easier to use, quicker to validate, and more effective at managing GxP activities. ZenQMS supports key quality processes, including: Document management/document control Training management and learning management CAPAs (Corrective and Preventive Actions) Deviations, nonconformances, complaints, issues, and other quality events Change controls Audit management Supplier and vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting -
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SBS Quality Database
Sunday Business Systems
The SBS Quality Database is a simple, inexpensive, ISO 9001 compliant software program that allows small businesses to efficiency manage the Quality Management System or QMS. The database tracks corrective actions, preventive actions (CAPA), internal audits, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Document interested parties as part of the Context of the organization. Use the dashboard for a quick view of the overall performance. Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001:2015, API Q1, AS9100, or TS16949 compliance. Free demo downloads are available from our website so you may try before your buy.Starting Price: $499/one-time -
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PaKalite
PaKalite
PaKalite is a quality management system for small and mid-sized automotive and industrial manufacturers, built on IATF 16949, ISO 9001/14001/45001, AIAG (PPAP, APQP, MSA, SPC) and VDA 6.3. 17 integrated modules: PPAP (18 elements, PSW, MSA/GRR), APQP (5 phases), audits (14 types, question bank, scoring, findings to CAPA), KPI scorecards (targets, deviation alerts, supplier rating), inspection & control plans (12 types, SPC Cp/Cpk, quarantine, EN 10204 certs), calibration, drawing revision control, nonconformity (NCR/8D), continuous improvement (Kaizen, 5S), supplier quality, management review, meetings, HR competence and training, TPM maintenance, OHS, and document management. Modules feed each other: an audit finding opens a corrective action; a chronic KPI deviation triggers one automatically. Cloud data with a Windows desktop client and an Android shop-floor app. PDF reporting, Excel import, role-based permissions, per-company data isolation. Free plan. Turkish interface.Starting Price: $0 -
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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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QFacts
QFacts
QFacts is a cloud-based Quality Management System for pharmacies, compounding facilities, and regulated industries. It covers the full quality lifecycle: controlled document management with version control and approval workflows, training and competency tracking with curriculum-based assignments, event and complaint handling, root cause investigations, CAPA management, and change control. All with complete audit trails. Built for GAMP 5 and European GMP/GDP compliance, QFacts enforces role-based access control across organisations, sites, and departments. Quality managers configure review workflows, track due dates, and monitor compliance through real-time dashboards. Every action is logged and traceable, giving inspectors and auditors a clear chain of accountability from document approval through training completion to corrective action closure.Starting Price: $17/month/user -
21
Quality Forward
Quality Forward
Quality Forward is a cloud-based electronic Quality Management System (eQMS) designed to help organizations in highly regulated industries digitize, manage, and automate their quality processes within a unified platform. Built on the ServiceNow architecture, it enables teams to centralize and control critical workflows such as deviations, corrective and preventive actions (CAPAs), audits, complaints, change control, document management, training, supplier quality, and risk management, all with full traceability and audit-ready documentation. It provides real-time monitoring, automated workflows, and AI-driven insights that streamline compliance, reduce manual effort, and improve operational efficiency across the product lifecycle. It offers a highly configurable, no-code environment that allows quality assurance teams to adapt processes to evolving regulatory requirements without relying on IT, while maintaining adherence to global standards such as FDA, ISO, and GxP. -
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Clearlane CAPA
Clearlane Apps
Clearlane CAPA is a Jira Cloud app for quality and regulatory teams managing corrective and preventive actions in medical device, pharmaceutical and ISO 9001 manufacturing environments. Existing Jira work items—including complaints, nonconformities, deviations and audit findings—can become CAPAs without new issue types, workflows or fields. The guided process covers containment, Five Whys root-cause analysis, a signed action plan, linked Jira actions and a dated effectiveness check; an ineffective check returns to root-cause analysis. Teams can review similar CAPAs, search CAPA data with JQL, export CSV and generate a PDF evidence file with workflow history, actions, signatures and audit trail. CAPAs can also start from Jira Service Management requests. A read-only Rovo agent answers questions about CAPA records. Built on Atlassian Forge, the app keeps its records in the customer’s Atlassian site.Starting Price: $59/month -
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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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QSE SMART
CY Innovations
QSE SMART is a quality, safety, environmental and risk management software application developed especially for small to medium-size business organizations and projects of 5 to 500 users. QSE SMART provides a solid framework that complies with key requirements of ISO9001, 45001 and 14001, and simplifies the day-to-day running of your integrated QSE management system. QSE SMART makes ISO make sense in your business. Designed around a risk-based approach according to ISO 31000, QSE SMART helps you to capture and exploit the key information and metrics that support your business objectives in respect to quality, safety, environmental and business risk management including your objectives and targets, management reviews, risks and opportunities, non-conformances and improvements, audits and inspections, accidents, incidents and hazards, corrective actions, equipment calibration and control of documented information.Starting Price: $3742.28 one-time payment -
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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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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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iPassport
Genial Genetic Solutions
iPassport is a managed software service designed specifically for healthcare laboratories to help digitize, streamline and improve the day to day management of quality and compliance. iPassport provides a complete suite of quality management modules, allowing you to easily keep on top of everything from document control to staff training. All your controlled documents stored in one place with appropriate access and edit permissions and full revision history. Everything you need to keep on top of internal and external audits. Record and manage NCs, CAPAs and incidents. Manage staff training and competencies, tasks, meetings and leave. A complete supplier database and audit tool including performance reviews. Manage and track assets and stock including equipment maintenance records. -
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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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QualSmart
QualSmart.ai
QualSmart is a cloud-based Quality Management Software (QMS) that helps organizations digitize, standardize, and manage quality and compliance processes through configurable solutions tailored to their business needs. The platform offers dedicated products for document management, audit management, corrective and preventive actions (CAPA), supplier quality management, training management, laboratory information management (LIMS), environmental monitoring, regulatory management, specification management, digital records, recall management, and visitor management. Designed for organizations in Food & Beverage, FMCG, Manufacturing, Packaging, Chemicals, Cosmetics, Hospitality, and Retail, Qualsmart enables teams to replace manual quality activities with structured digital workflows, automated approvals, configurable forms, notifications, dashboards, and reporting. Organizations can improve process consistency, maintain accurate quality records. -
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Pyraman
Pyraman Management Solutions
Pyraman is a business management system software platform designed to help organizations streamline quality, compliance, and EHS operations. The platform includes core modules for document management, record management, non-conformance management, audit management, complaint management, training management, objective management, and minutes of meeting management. Pyraman also offers add-on modules such as legal register, incident management, HIRA, aspect impact, and calibration management. The software helps businesses move away from paper-based processes by centralizing documents, records, workflows, and compliance activities in one digital system. Its real-time collaboration and document security features support better process control, accountability, and operational consistency. By combining QMS and EHS capabilities, Pyraman helps organizations save time, reduce costs, and improve compliance management.Starting Price: ₹60000 -
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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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QualityKick
SoftDoit
QualityKick is a QMS compliance solution in the cloud for quality management of the biological sciences. It consists of different modules; each of them solves a specific part of the quality management processes: document control, training, change control, events, CAPA, risk assessment, qualification, and audits of suppliers and equipment. As it is a web-based application, it can be accessed from anywhere and from any device mobile. Works everywhere: computer, smartphone, and tablet. Guided tour which loads automatically when new users log in for the first time. Allows you to edit documents with MS Word and send them through a configurable review and approval process. Different types of events can be configured such as deviations, nonconformities, or complaints. It is possible to define CAPA plans, record the actions, and verify their effectiveness. Solutions for quality management in the pharmacy, biotechnology, and medicine sectors. -
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Q-Med Database
Sunday Business Systems
The Q-Med Database is an ISO 13485 compliant database to efficiently manage corrective and preventive actions, nonconformances, internal audit schedules and findings, safety improvement, supplier corrective actions, continual improvement projects. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Compile and analyze Customer Survey results. Document QMS review meetings and results. Cloud based or locally installed options are available. The Q-Med Database is ideal for small businesses striving for ISO 13485 compliance. CFR21 Part 11 compliant.Starting Price: $1900.00/one-time -
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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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QISS Quality Management System
Quality Institute of America
Document Control is a document management service whose purpose is to support controlled processes and practices for creating, reviewing, correcting, issuance, and distributing of documents. ISO standard-based QMS QISS Offers CAPA Management Software System for Automating Corrective Action Processes in Regulatory Environments. Adopt your own risk-based thinking. Centralize to prevent and mitigate your risks. Standardized workflow helps you stay in control of changes in your organization. Build a paperless document management system with numerous additional benefits. Develop a culture of continuous improvement with the visibility of each non-conformance. -
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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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YunQuality
YunQuality Information Technology
Improve incoming parts quality and supplier quality performance,reduce the risk of production interruption, optimize the total cost of ownership, and manage supply chain risks. Monitor the in process quality performance and change of the trend through the whole flow of production, take preventive actions to reduce failure rate. Manage and control the quality of to-be-shipped out products, improve product competitiveness. Customer focus. Quick response to customer complaints, Improve the service and quality, improve customer satisfaction. Record and follow up corrective action and preventive actions.Realtime display of the task progress of each member.Enhance the capability of continuous improvement and improve corporate quality management system. Reduce the time on preparing audits, Improve the efficiency and effectiveness of audits. Mechanism in place to facilitate the audit as scheduled to be compliant with the requirements and regulations. -
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FactoryQA
FactoryQA
FactoryQA is an all-in-one Quality Management software for Manufacturers. Software Features: 1. Non-Conformance/CAPA Management 2. Document Control 3. Work Instructions 4. Inspection Sheets 5. Audits 6. Analytics Services: 1. ISO Certification Consultants 2. ISO Certification Workshops 3. Fractional Quality Management ServicesStarting Price: $1200 per year -
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E-Data Now!
E-Data Now!
Drive exceptional quality and process performance with a platform that puts you in cruise control. Crush poor quality, safety concerns and redundant processes with the all-in-one E-Data Now!® Audit and Quality Inspection platform, that includes the tools you need to connect your team performance, simplify checklists, root cause non-conformance, improve processes and grow customer satisfaction. E-Data Now! is a leading manufacturing, construction and site safety/compliance no-code, cloud-based platform, that digitizes quality inspection and process audits, automates workflows and provides mobile data-driven insights. The obvious benefit – clearing out your paperwork, cleans up the clutter in your audit processes and identifies unknown audit redundancies. The simple answer – a custom form creation and mobile data collection platform with digital tools made for the trades: to train, record, capture, react, correct, schedule, comply and build better processes. -
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Ideagen Supplier Management
Ideagen
Ideagen Supplier Management is supplier quality software that unifies supplier qualification, performance monitoring, non-conformance and supply chain risk in one platform, replacing supplier data scattered across spreadsheets and email threads. AI-guided workflows standardize supplier assessments and onboarding while keeping the audit trail complete. Automated scorecards track quality metrics and identify trends. Non-conformances trigger corrective action workflows covering root cause analysis, resolution tracking and effectiveness monitoring. AI assesses performance data, market conditions and compliance status to give early warning of supply chain risk, and drafts reports that your team reviews and approves. Supplier communication is centralized, with automated notifications. Connects with ERP and document management systems. Serves automotive, aerospace and defense, pharmaceutical and medical device manufacturers. -
41
Kapture.io
Kapture Global Quality
Kapture.io is an industrial quality management system (QMS) for manufacturers and other industrial organizations. It helps quality and operations teams digitize factory-floor controls and connect quality processes, production data, and records. Teams can manage control plans, monitoring guidelines, inspections, audits, supplier quality, instruments and calibrations, nonconformities, corrective actions, and problem-solving workflows. The platform captures quality data, maintains traceable records, and provides dashboards and reports for reviewing performance and investigating issues. Configurable workflows support consistent controls across production lines and facilities, while integrations connect quality processes with ERP, MES, and other plant systems. Kapture.io is offered as a cloud-based SaaS product.Starting Price: €24/month -
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Sercle QMS
Sercle
Delivering Quality Management Software to help manage your compliance against ISO standards. Such as ISO 9001, ISO 13485, ISO 17025, FDA, GMP, BRC. EQMS software is being placed into many different companies within different industries and with different ISO requirements with an overarching goal of helping in achieving product quality and optimum standards. Some EQMS applications are better suited as enterprise quality management systems and other systems for small to medium-sized businesses however regardless of setting, below are some key points that components of any of the best quality management software out there. Businesses may implement a quality process like CAPA (Corrective Action Preventative Action) into their EQMS software and this process may look different from one business to another even if they belong to the same sector. The ability to customize the workflow, fields, layouts to adapt to the behaviour of the business ensures a smooth implementation. -
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Qualiex
ForLogic
Quality Management Software. Overcome the challenges of Quality in your company with the software rated as the easiest to use. More than 45,000 professionals are already simplifying their management systems. Ask questions about Qualiex via Online Chat. In addition to email and phone, you can chat in real time with ISO 9001 Lead Auditors during our office hours, taking questions quickly and conveniently. Non-Compliance Management. No more feeling lost in the non-conformity process. Forlogic Tracker will eliminate spreadsheets, automate the charges made by email, centralize your information and evolve your NC management. Be more efficient in dealing with non-conformities by managing the main causes. Looking back, we can see that Quality has undergone several transformations. We have already lived through the era of Inspection, the era of Statistical Control and then Total Quality Management.Starting Price: $1500 per month -
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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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Intact Platform
Intact
The Intact Platform is the leading cloud and on-premise Enterprise Resource Planning (ERP) solution for audits, assessments, certification, accreditation, and standards worldwide. It goes beyond other audit collection tools on the market with a full solution approach that helps you manage communications, business goals, and personnel. The Intact Platform is unsurpassed in functionality and features a fully modular end-to-end workflow that is easily scalable. ✓ 34% increase in efficiency on average (up to 60+%) ✓ Unmatched modularity, flexibility, and scalability ✓ All standards and audit services ✓ Digital workflow – no paper ✓ On-site and remote auditing ✓ Non-conformities & corrective actions ✓ Risk-based auditing & planning ✓ Easy client communication ✓ Reporting & business intelligence (BI) ✓ Central data and management hub (incl. full audit trail) ✓ Nonstop innovationStarting Price: On request -
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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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Audit Manager
Focus Informatica
Audit Manager is the software supporting quality management that allows digital management of audits, quality controls and tests in all their phases: planning and compilation through checklists, collection of evidence and field surveys, verification and management of the entire nonconformity flow, definition of corrective actions and data monitoring. Access the calendar and schedule the audits by associating the relevant information with each one (subject, checklist, lead auditor, co-auditor, participants, etc.). The staff involved, both internal and external, can receive an invitation via email and consult the prepared audit schedule directly from the app. Once the inspection is completed, generate the audit report in PDF or Excel and share it directly from mobile with the company management or managers. The archive of all minutes is always available and organized and you can add it to the document repositories used by the company. -
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qmsWrapper
qmsWrapper
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance. Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.Starting Price: €3,499 -
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Fast Quality Software
Fast Quality Software
Fast Quality Software is a comprehensive quality management solution designed to streamline quality assurance processes across various industries. Fast Quality Software facilitates the management of quality-based processes such as non-conformance and corrective actions, improves data integrity and consistency, enforces controlled and repeatable processes, and provides audit information and reporting. It aids in measuring the cost of quality/non-conformance, communicating quality across the enterprise, capturing necessary quality data for compliance, identifying improvement opportunities, and managing changes. By implementing Fast TQM Software, organizations can improve product quality, lower production costs, enhance decision-making, maintain traceability and compliance, monitor supply chains, decrease human error, minimize waste, reduce inventory costs, and optimize manufacturing process efficiency. -
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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
