Alternatives to CAPA Manager
Compare CAPA Manager alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to CAPA Manager in 2026. Compare features, ratings, user reviews, pricing, and more from CAPA Manager 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
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 -
5
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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TenForce
TenForce
Track, analyze and report on your EHSQ processes from a single platform. Automate workflows, centralize data and simplifiy collaboration across departments. TenForce offers various integrated modules to help streamline processes such as Audits, Incident Management, CAPA, Permit to Work, Management of Change, and Shift Management. It offers mobile capabilities, which allow field workers and inspectors to access the software on mobile devices. Its built-in data analytics and reporting functionality enables managers to gain insights into the processes and risks of their industrial plants or public infrastructure assets. This visibility helps them address environmental, health, safety, quality, and compliance issues. TenForce helps manufacturers optimize their established processes while minimizing incidents.Starting Price: $9000 per year -
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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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EHS Insight
EHS Insight
EHS Insight is an environmental, health and safety (EHS) management platform that empowers organizations to ensure company-wide compliance. Affordable and quick to setup, EHS Insight offers the best value in EHS software today by providing businesses with the tools they need to manage incidents, audits and inspections, compliance obligations, corrective actions and more. EHS Insight also comes with fantastic support to assist businesses during and after software implementation.Starting Price: $200.00/month -
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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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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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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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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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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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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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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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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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CorrectTrack
CorrectTrack
Corrective Action Workflow. Create Actions. Team leaders and internal auditors can create and assign corrective action tasks from any device. Team members are notified immediately of the new task. Teams stay informed with automated notifications of changes in task stage and approval status. Dashboards, query filters and costume searches helps teams keep leadership informed. Permission based approval-gates help teams ensure tasks are investigated, corrected and the corrective action is verified before the task is closed. What does CorrectTrack do? CorrectTrack is a workflow that gives control over the entire corrective action process. With CorrectTrack you can: Assign corrective actions to team members. Create permission-based workflows to control the process. Communicate task status to team members and leadership. Create dashboards to quickly view performance. Retain evidence and produce reports of who did what and when to investigate.Starting Price: $5.29 per user 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. -
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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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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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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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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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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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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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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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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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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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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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Total Quality System 9000
ISP Software
With flexible TQS9000 deployment and licensing options, implementing our full QMS Software, CAPA Software, APQP Software, and Gage Control solutions are both fast and cost effective. No matter if you are looking for a single user, or to deploy a TQS9000 QMS Software solution enterprise wide, we are here to support your needs. Whether you are implementing a full QMS Software system, or choosing to implement our CAPA Software, APQP Software, or a TQS9000 custom solution, our products have the flexibility in deployment you need. Access your TQS9000 system on our cloud, your cloud, internal servers, or by installing on local workstations. Our TQS9000 QMS Software team has real world experience and understand that each customer is unique. Our team members will be there long after your purchase with the expertise to help your team acheive its goals. -
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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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EHSpro
BasicSoft Inc.
EHSpro is a cloud-based Environmental Health & Safety (EHS) management platform built for organizations that need to manage workplace safety, regulatory compliance, and risk mitigation without complexity. Core modules include: Incident Management with built-in investigation tools (5 Whys, Fishbone diagrams) Safety Training tracking and certification management Audits & Inspections with mobile-friendly checklists Permit to Work system for high-risk activities Lockout/Tagout (LOTO) procedure management Job Safety Analysis (JSA) documentation SDS Management and chemical inventory Document Management for policies and SOPs OSHA recordkeeping and compliance reporting Key features: Modular design: pay only for what you need Free tier available for every module Mobile-responsive for field use Multi-location support with role-based access Integrated CAPA (Corrective Action) tracking across all modules OSHA 300/300A/301 automation Built by BasicSoft. 30+ Years Exp.Starting Price: $20/month/seat -
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ProcessMAP
ProcessMAP
Streamline processes and manage associated risks with the most integrated suite of Health & Safety software solutions. With ProcessMAP, companies establish consistency and provides realtime insights to improve your Health & Safety performance and ROI. Streamline, standardize, and track processes essential to various regulations and compliance frameworks. Built-in alerts, robust CAPA management, and advanced reporting capabilities increase accountability, provide visibility across the organization, and keep you ready for audits and inspections. Reduce risk through the correlation of safety and claims experience data. Identify and mitigate unsafe activities and associated risk by analyzing the root cause of events and claims. Our platform helps reduce risk by stopping claims before they happen. Manage sustainability performance and metrics reporting with the industry's leading cloud platform. Streamline collection, verification, and analysis of company-wide KPIs. -
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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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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. -
42
FORM OpX
FORM.com
Compliance software that drives operations. Improve safety and increase accuracy with the top mobile audit and inspection platform for teams trusted by Walmart, Wendy’s, and Fannie Mae. Upgrade your paper, Excel, and digital processes to the #1 field management platform for teams. FORM OpX combines advanced data collection and configurable workflows with powerful operational insights to boost compliance in real-time. Configure audits, inspections, and workflows to ensure teams consistently follow procedures and meet regulatory obligations. Capture data instantly with digital forms that guide teams to the right action. Configure automated alerts and escalations to trigger corrective action as soon as issues arise. Save time and money with customizable workflows that improve processes and increase compliance — everywhere. -
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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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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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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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qmsWrapper
qmsWrapper
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. Document Control: Intuitively manage documents for enhanced traceability and version control. Cloud-Based Accessibility: Access your QMS anytime, anywhere. Electronic QMS: Embrace efficiency with digitized QMS for faster approvals and real-time updates. Audit Management: Prepare for audits confidently with scheduling, tracking, and reporting tools.Starting Price: $500/month/10 users -
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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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ConvergePoint Incident Management
ConvergePoint
ConvergePoint’s incident management software simplifies and strengthens how organizations conduct their investigations. Built on Microsoft 365, our platform centralizes incident reporting, automates workflows, provides role-based access, and enhances root cause analysis, corrective actions, and case resolutions. -
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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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Riskonnect
Riskonnect
Riskonnect is a trustworthy and reliable Integrated Risk Management system that offers a developing suite of solutions on a world-class cloud computing model, which empowers customers to promote their projects for the administration of all risks across the enterprise. Riskonnect enables organizations to comprehensively grasp, oversee and control dangers, positively affecting shareholder value. Riskonnect's exceedingly configurable technology is perfect for groundbreaking associations confronting increased examination and accountability for corporate governance, strategy, and strategic risk. The incorporated arrangements encourage the capacity to get ready for and respond intelligently to all risks that could potentially hurt an organization and its' competitive position, harm the corporate reputation and limit key development. Once completely incorporated, Riskonnect's features include Auditing, Business Process Control, Corrective Actions (CAPA), Risk Assessment, and Compliance.
