Alternatives to MyBlueLabel

Compare MyBlueLabel alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to MyBlueLabel in 2026. Compare features, ratings, user reviews, pricing, and more from MyBlueLabel 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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  • 2
    Propel

    Propel

    Propel Software

    Propel is a cloud-native platform that unifies PLM, QMS, and PIM in one connected system, giving manufacturers complete visibility and control across the entire product lifecycle. It provides a single source of truth for product data, streamlines change management, strengthens quality and compliance, and accelerates time-to-market by eliminating silos. With real-world AI use cases and enterprise-grade security, Propel helps organizations reduce errors and improve cross-functional alignment. Agentic AI accelerates change reviews, surfaces BOM and quality risks, enriches product information, and guides decisions—while role-based permissions and audit trails protect IP. From design through manufacturing and commercialization, Propel empowers companies to deliver innovative, high-quality products faster with greater confidence. Each module deploys independently with no required dependencies.
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  • 3
    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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  • 4
    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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  • 5
    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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    TenForce

    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

    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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    ComplianceQuest

    ComplianceQuest

    ComplianceQuest

    Fastest growing Enterprise Quality, Health and Safety Management System (QHSE) natively built and run on the Salesforce platform. Unified QHSE solutions, which combine EQMS and EHS, help our customers of all sizes deliver quality products and services in the safest, most sustainable way by mitigating risk, problems, and inefficiencies while protecting customers, employees, suppliers and brand. Every organization – irrespective of its industry, geography or size – involves an interaction of activities and processes with the environment. These activities may have an adverse or favorable impact on the environment depending on the type of activity being carried out. Our Environment Management solution has been designed to minimize and mitigate these adverse impacts on environment, to such an extent that our already depleting biodiversity is protected, and nurture an ecosystem where all living organisms coexist sustainably.
    Starting Price: $30 per user per month
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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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    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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    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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    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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    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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    ACE Essentials

    ACE Essentials

    PSC Software

    Reduce risk with ACE Essentials, the pre-validated Electronic Quality Management System (EQMS) software created for all highly regulated industries. ACE Essentials comes equipped with 10 workflows built in and all the necessary Standard Operating Procedures and Policies, resulting in a fully compliant quality management system from the beginning. Understand the risks associated with your assets with ACE Essentials features including a full audit trail tracking every single action in the system. Pre-Configured Workflows. Pre-Configured Event Management (Due Dates, Scheduling and Reminders). Pre-Configured Permission-Based Security. Full Documentation Pre-Configured. 50+ Documents. Multiple Site Capability. Free Upgrades Throughout the Life of the Product. Pre-Configured Tasks List. No Validation Time. Pre-Configured In-System Notifications. Pre-Configured Email Notifications
    Starting Price: $500 one-time payment
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    Cority

    Cority

    Cority

    Proven solutions to operationalize your pandemic response plans, systematically monitor, and report on the health status of your employees and visitors, and assist your business’ return to productivity. Improve your safety culture by engaging employees, enhancing workflows, and increasing data visibility across all levels of your organization. Cority helps you break down departmental silos, improve reporting, and achieve operational excellence. Cority's unified compliance management solution is designed to help you take the guesswork out of compliance. myCority connects your frontline employees no matter where they are with the tools they need to mitigate risk and drive compliance. EHSQ experts design, implement and support the Cority solution. That’s why we are the leader in Occupational Health, Industrial Hygiene, and Employee Health solutions. Take your safety programs to the next level by proactively mitigating risks, managing compliance, and reducing incidents.
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    FORM OpX

    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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    Virje

    Virje

    Virje

    Virje complies with the requirements of 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. Overwhelmed by the thought of Part 11 software validation? Accessible from wherever you are, for whenever you work. Eliminate paper, reduce cost, and increase efficiency with automation and centralized collaboration. Perfect for small to medium-sized businesses. Built from the ground up specifically for medical device quality management. A system that is flexible enough to adjust to your workflows and processes, without having to compromise. Configurable change order approvals by employee role and by document type. Notifications to responsible personnel at every stage in the change process. Ability to designate material dispositions for individual documents. Easy access to released and historical versions of documents. Quick viewing of document change history. Tracking of where-used locations and distributed hard copies. Periodic document review notification.
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    SoftExpert EQM

    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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    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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    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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    GxPLABS

    GxPLABS

    GxPLABS

    GxPLABS is a digital solutions provider offering comprehensive end-to-end software products tailored for regulated industries. Their extensive product list includes systems for SOP management, document management, learning management, laboratory information management, quality management, and more. The platform is designed to be platform-independent, low code, and AI-based, supporting flexible deployment and customization. GxPLABS solutions comply with industry standards such as 21 CFR Part 11, Annex 11, ISO 9001, and ISO 27001, ensuring regulatory alignment. With over 10 years of experience serving customers across more than 10 countries, they provide expert client support and scalable, complex technology solutions. Businesses can also develop fully customized software using their platform to meet unique needs.
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    ZipQuality

    ZipQuality

    Consensia

    ZipQuality is a software-enabled service that assists medical device companies in bringing new products to market. Our collaboration platform manages rapid design changes for agile teams while ensuring regulatory compliance. Pre-configured system(processes and tools); no need to alter your quality system. The integrated system easily handles rapid design iterations for product documentation. Experienced consultants guide your team at every step. Fully-featured, scalable software tools built on the proven, powerful ENOVIA platform. Our integrated system enables rapid design changes while keeping product documentation and data in sync and maintaining all the records in an audit-ready state. Product requirements, hardware requirements, software requirements. We understand complex, software-intensive medical devices. The ZipQuality system is based on a structured documentation framework that supports good systems engineering, efficient risk management, and clear traceability.
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    SBS Quality Database

    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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    Quality Connect
    Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements.
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    Panotica Hydra 4.0
    Panotica Hydra is a modular QMS software for managing quality processes according to the requirements of ISO 9001, 14001, 18001 and other similar ones. The software allows not only to gather all of the company’s improvement processes in one system, but also to actively integrate all of the employees on the system platform. Hydra provides access to supervise activities remotely aimed at improving quality as well as engages company’s employees in the improvement process.
    Starting Price: $9 per user per month
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    Greenlight Guru

    Greenlight Guru

    Greenlight Guru

    Greenlight Guru’s Medical Device Success Platform is the only all-in-one solution that helps you get your products to market faster, with less risk, and advance your success in-market. The platform helps companies manufacture safer products and get to market faster, simplifies regulatory compliance, and provides a single source of truth by connecting the management of all product development, regulatory, and quality processes from documentation and design controls to submission and ongoing compliance. Device makers across the globe are replacing reactive quality management tools and shifting their focus and efforts to ensure successful product launches and in-market success of innovative, life-changing devices.
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    ZEBSOFT

    ZEBSOFT

    Zebra Software

    ZEBSOFT GRC & ISO management software platform is a holistic approach to managing Governance, Risk & Compliance. With an intuitive and easy to use web interface, ZEBSOFT makes to easy to manage ISO (9001, 14001, 22301, 27001, 45001) and many other standards. ZEBSOFT has powerful integrated modules for Risk, Quality, Environmental, InfoSec, Compliances, policies (templates included) & documents, equipment & asset management with maintenance/calibration/testing planning. Improve internal communication, assign ownership, plan and carry out audits. Book a demo today to see what ZEBSOFT can do!
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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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    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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    Wismatix QMS
    We know that for a system to be used it needs to be accessible! You don’t want to wait for pages to load or searches to finish. You want to be able to add a record or get the information you need quickly and easily, whenever and wherever! Wismatix QMS lets you do just that. Based on many years of experience in auditing and implementing Quality Management Systems, we built Wismatix QMS for excellence regarding speed and reliability. Wismatix puts customer service above the rest. Not only will you have full support during the use of your online quality management system, but in the event, you no longer require the use of our system, we vow to send your data to you to upload on your own server for your use. Wismatix puts customer service above the rest. Not only will you have full support during the use of your online quality management system, but in the event, you no longer require the use of our system, we vow to send your data to you to upload on your own server for your use.
    Starting Price: $30 per user per month
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    CASQ-it

    CASQ-it

    BÖHME & WEIHS

    Defect-free business processes lead to defect-free products. And that is exactly why CASQ-it is designed to encompass all the steps in your quality assurance and quality management processes – starting with the development process, continuing through the material process – up to and including your support processes. The advantage of CASQ-it lies right here in this process-oriented mode of operation – functionality that enables your CAQ system to adapt flexibly to your processes – and not vice versa. CASQ-it supports your quality assurance processes on their journey into the future: Quality and reliability increase customer satisfaction whilst reducing the cost of quality. Each separate CASQ-it module functions independently – enabling you to optimize individual processes and workflows within your company right from day one. Our modules can be flexibly combined – or used to create a comprehensive quality assurance system.
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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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    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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    ZenQMS

    ZenQMS

    ZenQMS

    ZenQMS enhances the quality compliance profiles of life sciences companies via a cloud-based platform, purpose-built to manage document collaboration and control, training, issues, change management, and audits with ease. The ZenQMS team is comprised of both technology and quality leaders with the shared mission of elevating quality management to be a business imperative.
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    AssurX

    AssurX

    AssurX

    The AssurX platform is a versatile enterprise quality management system (EQMS) and regulatory compliance management platform. AssurX allows enterprises of any size or complexity to create a system that reliably communicates and coordinates quality and compliance information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. AssurX QMS software is highly configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify.
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    Cognidox

    Cognidox

    Cognidox Ltd

    Cognidox is an online document management system for high-tech, medical device and life sciences product development sectors. Available in the cloud or as an on-premise solution, Cognidox promotes better product lifecycle management and knowledge transfer from developers to clients, partners, and customers. Secure and reliable, Cognidox provides plug-ins for various programs such as Microsoft Office, and we also offer a robust API so that you can integrate almost any process with Cognidox In addition to the core function as a DMS, an add-on for Cognidox also offers a way of allowing licensing and distribution of documents to third parties via fully sandboxed site so you have the power to publish specific documents whilst keeping your main storage secure. Another popular add-on is the gBMS - graphical Business Management System, Use Visio to easily capture your business processes, a good BMS should give you clear oversight of your entire operation.
    Starting Price: £10 p/user
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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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    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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    QEdge

    QEdge

    Sarjen Systems Pvt Ltd

    Sarjen’s Quality Management Software brings meaningful digital transformation to how quality is managed across regulated manufacturing environments. More than just a system to store compliance records, it uses AI to turn quality data into actionable insights. AI analyzes trends, spots early signals of deviation, and predicts potential quality risks before they impact products or processes. Automated alerts and intelligent recommendations help teams act faster, reduce manual errors, and strengthen decision-making with context-aware guidance. With machine learning, the system continuously learns from data patterns and improves accuracy over time. By combining robust quality workflows with AI-driven intelligence, the solution enhances product consistency, accelerates investigation cycles, and ensures stronger compliance. It makes quality management smarter, more proactive, and easier for your teams to adopt and trust.
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    Ennov Quality Suite
    Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency
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    CAQ.Net

    CAQ.Net

    CAQ AG Factory Systems

    CAQ AG Factory Systems has established itself as one of the worldwide leading providers of quality management software. We have over 30 years of experience in the development and distribution of modular, multilingual, and industry-specific management solutions for small and medium-sized enterprises as well as multinational corporations. Our CAQ.Net software suite covers every aspect of computer aided quality assurance and was designed with the highest degrees of adaptability and customizability in mind. Just like a construction kit, our system allows you to pick the most suitable building blocks and thereby create the perfect solution to your individual quality management demands. Why CAQ.Net? Updates, Upgrades & Release Changes Support from QM & IT Professionals User Workshops Screencasts Conformity to Standards Information Security SaaS or On-Premises Floating Licenses Multitenancy Multilingual No-Code-Designer Validation Capability AI Assistants ...
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    Nova-QMS

    Nova-QMS

    Novatek International

    Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices.
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    Harrington Quality Management Software (HQMS)
    HQMS' applications include Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. In business since 1991 – trustworthy source with SME Experts in Sales and Support will help with Business Case, Flexibility (on-premise or hosted, CapEx and Opex pricing models) with Support and Training & deployment planning that provides rapid learning curve with implementation guides. Secure deployment – including Single Sign On (SSO). Configuration and personalization features with customization if needed. HQMS is used cross several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.
    Starting Price: $500/month
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    Quality Link

    Quality Link

    Quality Mapping Solutions

    Inspired by people and technology, Quality Link 7 builds on our experience and proven platform for helping organizations automate processes, save money, and achieve regulatory compliance with an easy-to-use business operating solution. Quality Link delivers improved efficiency while eliminating manual paperwork with our document management. Every document you create will be stored and managed from within this module. You can print “uncontrolled” copies of your documentation from within this module, as well as perform many other document-related activities. With the enhanced organization, you’ll see clerical tasks by quality personnel reduced by up to 90 percent. Our software effortlessly converts existing documentation from your previous management system, and there’s no learning curve. But you won’t miss your favorite applications, as they can be easily integrated. With Quality Link, you can say good-bye to manual document maintenance, which requires constant monitoring.