Alternatives to SoftExpert EQM

Compare SoftExpert EQM alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to SoftExpert EQM in 2026. Compare features, ratings, user reviews, pricing, and more from SoftExpert EQM competitors and alternatives in order to make an informed decision for your business.

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    Qualio

    Qualio

    Qualio

    Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling
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    AlisQI

    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 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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    Total Lean Management (TLM) Software

    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 Orders
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    Starting Price: $45/user/month
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    Dot Compliance QMS

    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-Shop
    Starting Price: $10,000 / Annually
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    SimplerQMS

    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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    Sunday Business Systems

    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.
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    Qualityze EQMS Suite
    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.
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    Starting Price: $30/User/Month
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    QT9 QMS

    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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    BPAQuality365

    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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    ARMATURE Fabric
    With ARMATURE Fabric™ you can manage your accreditation, certification, credentialing, audit, quality, and compliance activities within a single platform. Our software enables you to save time, operate more effectively and securely, and better serve your stakeholder communities. Whether you are managing institutional, programmatic, or specialized accreditation programs; certifying individuals, products, or organizations; conducting audits or assessments; or resolving non-conformances or other issues, ARMATURE Fabric can make it easier and more efficient for you and your stakeholders. Our secure, cloud-based software allows you to collect data in multiple ways (through online applications, audits, assessments, self-evaluations, inspections, forms, and surveys); manage your accreditation, certification, audit, and compliance workflows; capture and manage documents and artifacts, identify and remediate issues; generate reports; and spot new trends.
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    Artintech ERP

    Artintech 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).
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    Starting Price: $24.95/Module/Month
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    Intellect

    Intellect

    Intellect

    Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals.
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    Qualtrax

    Qualtrax

    Qualtrax

    Qualtrax is a complete quality and compliance software system used to manage and control documentation, automate key business processes with customizable workflows, streamline training management, manage internal and external audits and ensure critical industry regulations are addressed in real-time. Qualtrax is an invaluable resource in heavily-regulated industries, where complying with standards including ISO 17025, 17020, 13485, and 9001, TNI, GFSI, FDA, and FQS is required.
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    MasterControl

    MasterControl

    MasterControl

    Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.
    Starting Price: $25,000 / 1st year
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    1factory Manufacturing Quality
    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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    uniPoint Quality Management Software
    uniPoint's Quality Management Software is a modular on-premise quality management software. Quality Management Software can integrate with other ERP systems with ease. Quality Management Software is suitable for manufacturers of any kind of product in any manufacturing mode. With Quality Management Software, users can manage processes such as document control, equipment management, non-conformances, corrective/prevantative actions, and more.
    Starting Price: $6000.00/one-time
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    QualityPro by TecWork

    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 Management
    Starting Price: Contact us for pricing
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    Mango QHSE
    By integrating your Quality, Health, Safety & Environmental Management systems in the Cloud and on a Mobile App. Organizations who rely on Mango for their QHSE compliance come in all different shapes and sizes. Our clients are located across United Kingdom, Australia, New Zealand and South Africa. Our certifications to both ISO 9001 and ISO 27001 gives you the assurance that we manage our quality and your information security. Supercharge your consulting company's growth by building a new recurring revenue stream and delivering more value to your clients. Mango sets you apart from your competitors. And because it's in the cloud, there’s no question that Mango is also the future of the industry. With Mango in your tool bag, you're able to give your clients an easier, more cost-effective way of tackling their compliance obligations. Mango is a popular Compliance Management solution developed by Mango Limited.
    Starting Price: $250 per month
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    TrackWise

    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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    SoftExpert PLM

    SoftExpert PLM

    SoftExpert

    SoftExpert PLM is a software for Product Lifecycle Management (PLM). It enables companies to manage the entire lifecycle of a product efficiently and cost-effectively, from conception, design and manufacture, through service and disposal, in an affordable, easy-to-use, and web-based interface. SoftExpert PLM software can leverage enterprise-wide data to help managers make better decisions. It increases the optimization of every step of the product lifecycle, creating higher quality products, launching new products in less time and at a lower cost, and maximizing profits. The solution provides a complete product data management tool. It allows users to manage several process aspects, such as design, manufacturing, purchasing, quality/test, and service aspects of product records. Product data can be defined by any product object (parts/components, documents, Bill of Material [BOM], machines/instruments, costs, characteristics, etc.). SoftExpert PLM software manages all product revisions.
    Starting Price: $10000 one-time payment
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    Grand Avenue Software

    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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    SoftExpert FMEA
    SoftExpert FMEA is enterprise software that helps companies manage Failure Modes and Effects Analysis. Through a proactive approach, SoftExpert FMEA anticipates defects before they occur, thus allowing companies to ensure quality in their deliveries. FMEA can be applied to different contexts such as products, processes, departments, assets, and lowering the engineering workload, while also improving machines and availability of resources by identifying, analyzing, and improving high-risk components. The solution continuously monitors failures identified in FMEA, by showing reports and charts with indicators such as seriousness and risk priority, which highlight causes considered to be priorities at each moment. The solution helps to enhance product safety and reliability, increasing customer satisfaction.
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    MyBlueLabel

    MyBlueLabel

    MyBlueLabel

    Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated in your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.
    Starting Price: $235 per month
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    QualityKick

    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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    Paradigm 3

    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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    Qualiex

    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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    QCBD

    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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    SoftExpert Suite
    The SoftExpert Suite is a comprehensive solution designed to address critical business excellence challenges through an integrated multi-application environment. It offers a suite of interconnected components that can be scaled and expanded as business needs evolve, allowing for the incorporation of new functions. The suite aims to facilitate collaborative problem-solving and improve business performance by providing tools for corporate governance, risk management, compliance programs, and continuous business process improvement.
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    SoftExpert ERM

    SoftExpert ERM

    SoftExpert

    SoftExpert ERM software enables organizations to identify, analyze, evaluate, monitor, and manage their enterprise risks using an integrated approach. It brings together all risk management-related data in a single and comprehensive environment, including a reusable library of risks and their corresponding controls and assessments, events such as losses and non-conformities, key risk indicators, issues and treatment plans. The solution streamlines the risk assessment process, while the risk heat map feature enables organizations to set their priorities and make strategic decisions based on risk levels. The software serves as the foundation for the company’s enterprise risk management efforts through its ability to unite and support different risk categories like strategic, financial, security, compliance, environmental, assets, products, processes and projects.
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    BabtecQ

    BabtecQ

    Babtec Informationssysteme

    Quality management software. We manufacture and offer QM solutions for all quality tasks – as we have done for 25 years. As quality specialists, we have developed an all-round solution for quality management with our modular software BabtecQ. In addition, we offer Babtec Qube, a cloud-based platform with which you can interconnect with your suppliers and customers to edit your quality tasks. Our products allow you to depict the whole range of quality processes, both internal and across companies – for quality you will love to share. Would you like to refresh your knowledge about quality management? Then you have come to the right place! On our knowledge pages you can find out, for example, what complaint management or 8D report are all about. The System FMEA (also termed a system analysis) is a subsection of the FMEA (Failure Mode and Effects Analysis). It is intended to investigate an entire system and check whether all of the individual components within it work together correctly.
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    NiftyISO

    NiftyISO

    Niftysol

    NiftyISO 9001 Audit software streamlines quality management, ensuring compliance, efficiency, and consistency across your organization. Accessible on the web, mobile, and tablets, it empowers you to improve quality from anywhere, enhancing operations whether in-office or remote.
    Starting Price: $9 per month
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    SoftExpert ESG

    SoftExpert ESG

    SoftExpert

    SoftExpert ESG is an advanced 100% web-based ESG solution software for comprehensive strategic sustainability management involving environmental, social, and governance factors, transforming your ESG risks into value and opportunities and automating the end-to-end process. Through an integrated ESG software platform, you can structure processes and policies to effectively manage and control all ESG initiatives and indicators in your organization, using popular frameworks such as GRI, SDG, SASB, and MSCI, or even creating indicator models and custom reports. With a complete ESG solution, SoftExpert ESG improves data transparency and accountability, saving time and resources, while facilitating internal and external communication and engagement. Already popular frameworks (GRI, SDG, SASB, MSCI) or custom models can be created as needed by the company. Allows the organization's compliance level to be controlled and makes it easier to establish which actions need to be taken.
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    qmsWrapper

    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.
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    Starting Price: $500/month/10 users
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    Sierra QMS

    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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    IMSXpress ISO 9001
    IMSXpress ISO 9001 is a document control and quality system management software. The IMSXpress client application can be installed directly on user computers, or on a Windows server and then be distributed to users by remote desktop services as a remote application. The database is an MS SQL database. It can be installed on any MS SQL Server 2014 or higher and be accessed by the IMSXpress application over any type of network. You can set up your own remote access, use our cloud-based data hosting service, or get the online subscription package. Fully automated training system with self-training, integrated document training, job descriptions, and more. Use for document, engineering, and process changes. Make fillable PDF form templates, fill the forms with data, and create records. Use for scheduling and administrating maintenance, and for managing spare parts inventory. Manage complaints, non-conformities, risk management, audit findings, and more.
    Starting Price: $160 per month
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    Effivity

    Effivity

    Effivity Technologies

    Effivity is a cloud-based / on-premise QHSE/FSMS/ISMS software to implement a robust Quality - Occupational Health & Safety - Environment Management System & offers 100% conformity to ISO 9001, ISO 14001, ISO 45001, ISO 22000, HACCP standards. Effivity makes ISO compliance simple, easy, quick, value adding, cost-effective, collaborative and time-saving which results in enabling an organization to enhance efficiency and augment productivity as validated by users in more than 120 countries. Effivity offers a unique approach to optimize your management system with world-renowned QMS software, HSE software & FSMS-HACCP software. Simplicity, standardization and customer satisfaction delivered with no-code quality management system software, safe workplace enabled with 100% customizable occupational health & safety management system, sustainable environment possible with a user-friendly environment management system and safe food delivered with HACCP software that is ready to use.
    Starting Price: $30 per month
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    Metaware QMS Platform
    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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    FactoryQA

    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 Services
    Starting Price: $1200 per year
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    ISO 13485 Quality Management
    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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    QwizPRO

    QwizPRO

    Telonic IQ

    QwizPRO simplifies quality management for ISO 9001 and AS9100 compliance, ensuring stress-free audits. Its user-friendly automation minimizes errors, saves time, and streamlines the compliance process. QwizPRO is essential for today’s competitive business environment, enabling quality excellence that’s hassle-free. Monitor and evaluate each supplier consistently, ensuring they align with your stringent quality benchmarks. With real-time analytics and customizable reporting features, the software offers a clear view of supplier performance, highlighting areas of excellence and identifying potential risks. Empower your team with QMS training that is designed to elevate their knowledge from quickly understanding industry standards to mastering complex procedures. QwizPRO allows you to automatically deploy training, monitor learning progress, and identify areas for further development. Leverage QwizPRO for instant access to the right documents for daily tasks.
    Starting Price: $199 per month
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    Ideagen Qadex
    Food Safety Software enabling cost-effective transformation of food safety, NPD, customer complaints and supply chain transparency. Save time and complete consistent, auditable risk assessments of products & suppliers; our food safety software includes horizon scanning and VACCP/TACCP. Be audit-ready 24/7 and never receive an audit non-conformance, guaranteed. Transform specification management for raw materials, and finished products and answer product queries instantly. Automate supplier quality monitoring or internal non-conformance management with automated workflows to ensure prompt closure of non-conformances. Let our team manage the entire complaints process using market-leading software to save time, money and improve customer service. Deliver new product launches faster, better, together while ensuring that all safety, quality, legality and profitability requirements are met.
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    ProActive QMS

    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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    TRACKMEDIUM

    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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    QSE SMART

    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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    CAPA Manager

    CAPA Manager

    Adaptive Business Management Systems

    Automate the identification, containment, investigation, and resolution of problems within your organization and supply chain. Trusted by thousands of users globally, this is one of the best CAPA software applications available. CAPA Manager corrective action software automates the assignment, notification, investigation, reporting, and approval of corrective actions. It error-proofs the control of the entire CAPA process, from initiation to investigation and all the way through to closure. CAPA Manager meets the requirements of all important quality management standards: 21 CFR part 11, ISO 9001, AS9100, TS 16949, and more. It keeps records of root-cause and corrective action while providing pre-defined workflows and approval gates.
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    Starting Price: $12.49 per user/month
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    Fast Quality Software

    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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    QUMAS EQMS

    QUMAS EQMS

    Dassault Systemes

    To bring new products to market as quickly as possible in compliance with global regulations, organizations need to standardize and automate their business processes that manage the collection, tracking and analysis of information and the resolution of related issues. QUMAS EQMS (formerly ProcessCompliance) is a cloud-based solution for Enterprise Quality and Process Management that delivers comprehensive integrated regulatory, quality and compliance management capabilities in a validated QMS environment. QUMAS’s data-centric approach allows you to flexibly manage quality content and to access and re-use all quality data, providing comprehensive visibility into Quality. QUMAS’s interactive quality dashboards provide QMS overview across business areas and quality initiatives. Reports are available for export, email and scheduling. QUMAS allows QMS departments to exchange information securely, efficiently and compliantly in the cloud.
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    Scilife

    Scilife

    Scilife

    Revolutionize your Life Sciences processes. Drastically improve the control, efficiency, and quality of your processes and products. Ensure inspection readiness at all times through our fully compliant platform, pre-validated according to GAMP5. Maintain total control over processes and documents, customize workflows to perfection, and automate where possible. Enjoy uninterrupted workflows and full traceability through seamlessly connected and integrated modules. Our dedicated team is ready to answer your questions at any time. Only a first-class Scilife experience will do! Our Scilife platform streamlines automates and organizes every process in your industry space, whether you’re in Medical Devices, Pharma & Biotech, or ATMP. Click below to discover which Scilife modules support your unique industry lifecycle stages. Our software is equipped with all the advanced quality tools you would expect, and a bunch more that go above and beyond!
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    SoftExpert GRC

    SoftExpert GRC

    SoftExpert

    SoftExpert GRC is the solution to simplify governance, risk, and compliance management in your company. Ensure compliance with corporate policies, laws, and external regulations with a platform that effectively integrates business strategy execution with risk management practices. Manage all aspects of governance, such as risks, controls, requirements, internal audits, policies, and procedures related to organizational processes in a single environment. Get easy access to risk assessments, controls, and action plans associated with the organization's processes or activities. Automate repetitive activities and perform consistently, saving time and reducing process failures. Identify the root cause of compliance issues and quickly create corrective actions to resolve them. Communicate indicators and targets through fully visual and collaborative portals, increasing transparency in results.