Alternatives to Qualcy QMS
Compare Qualcy QMS alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Qualcy QMS in 2026. Compare features, ratings, user reviews, pricing, and more from Qualcy QMS competitors and alternatives in order to make an informed decision for your business.
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1
Intelex
Intelex Technologies
Intelex is an integrated software solution for managing Environmental, Health, Safety and Quality (EHSQ) programs. Intelex’s scalable platform is designed to store, manage and analyze EHS and Quality data in one place. The solution works on any device to meet the realities of your workplace. With Intelex, your organization can: - Drive better results in your EHSQ program by monitoring workflows to achieve top performance and gain control. - Identify trends and tendencies by setting goals to gain greater insight into your EHSQ program to enhance judgement. - Reduce incidents and administrative work by easily monitoring, managing, optimizing and drawing insights from your safety data with our user-friendly safety software solution. - Streamline air, water and waste emissions management and reporting, and track and manage environmental outputs to achieve sustainability goals. - Drive continuous quality improvement activities across multiple departments, sites or locations. -
2
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 -
3
isoTracker Quality Management
isoTracker Solutions Ltd
isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it. It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management. It can be configured to meet an organization's specific needs and provides free training and free support. It has been independently judged to provide the best customer support in its category. -
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SBS Quality Management Software
Sunday Business Systems
The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server. Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - EHS module SBS Ground Control - Employee training management (LMS) - Document control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans Great product for efficient and affordable QMS Compliance -
5
Total Lean Management (TLM) Software
Lean & Mean Business Systems
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work OrdersStarting Price: $45/user/month -
6
Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
7
LIMSey
LIMSey
LIMSey is a web-based software designed to help engineering and mechanical test labs manage their entire process within one system. Assign and schedule resources, track job progress, manage ever-changing priorities, generate custom test reports, support regulatory audits and accreditation, manage equipment, maintenance, calibrations, training records, and more. All features, updates, and support are always included with no additional modules to buy. We focus on continuous improvement and regularly meet with our existing customers to plan and discuss new features. This collaboration helps drive the development of LIMSey to solve more and more real world problems faced by test labs. Most of our new features come directly from customer requests/. We're also very familiar with ISO / IEC 17025 and would love to help with your initial accreditation or renewal. Call us today at 512-537-9323 for a demo or free trial and start managing your entire lab from one place. -
8
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 -
9
Sunday Business Systems
Sunday Business Systems
Sunday Business Systems (SBS) offers comprehensive quality management software (QMS) and consulting services to improve compliance with quality management standards, including ISO 9001, AS9100, ISO 14001, ISO 45001, and ISO 13485. Our solutions, such as Corrective Action and Preventive Action (CAPA) management, document control, and employee training management, help businesses streamline operations while ensuring compliance with industry regulations. SBS provides software tools for a full rangce of systems including audit management, calibration control, Preventive maintenance, EHS tracking, vendor management and inspection data collection and statistical process control (SPC). SBS provides on-premise and cloud-based solutions and customized software tailored to the unique needs of small businesses, improving productivity and operational efficiency. SBS offers the best value in QMS software.Starting Price: $295 -
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Qualityze EQMS Suite
Qualityze
Qualityze is a leading provider of cloud-based Quality Management System (QMS) and Enterprise Quality Management Software (EQMS) solutions built natively on the Salesforce platform. Designed to streamline quality processes, ensure regulatory compliance, and drive operational excellence, Qualityze empowers organizations to manage CAPA, audits, document control, training, change management, risk management, and supplier quality within a unified, scalable ecosystem. Focused exclusively on quality and compliance, Qualityze delivers purpose-built QMS and EQMS solutions without distractions from unrelated custom development. Our platform enables organizations across life sciences, manufacturing, and other regulated industries to simplify compliance with global standards while improving visibility, traceability, and accountability. Qualityze fosters a true culture of quality by making enterprise quality management intuitive, user-friendly, and collaborative.Starting Price: $30/User/Month -
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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 -
12
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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[FP]-LIMS Software
Fink & Partner
The [FP]-LIMS modules are based on a powerful SQL database solution. These allow a quick query and processing of data. We guarantee maximum user-friendliness! Our job server is a central element for the automation of functions, which executes time- and event-controlled tasks. Like, to automatically monitor limit values and the associated alarm message (e-mail, message on the monitor, etc.) when they are exceeded. Using modern LIMS software and modules such as analysis management, inspection planning, workflow management, or ERP, you can design your quality management in the best way. This makes your production processes more efficient.Starting Price: $2500 one-time fee -
14
Artintech ERP
Artintech
Artintech ERP is a comprehensive enterprise resource planning solution designed to optimize and streamline your business operations across various departments. Tailored for small to medium-sized enterprises (SMEs), Artintech ERP offers robust functionality with a user-friendly interface, allowing businesses to seamlessly manage their resources, inventory, human capital, finances, and customer relations all in one integrated platform. Artintech ERP includes a wide range of modules designed to optimize business operations. Key modules include Procurement, Warehousing, CRM, Distribution, Quality Management (QMS), Workplace Safety, Document Control, Non-Conformance and Corrective and Preventive Actions (CAPA), Inspection, and Computerized Maintenance Management System (CMMS).Starting Price: $24.95/Module/Month -
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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 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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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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Veeva Vault QMS
Veeva Industries
Ensure quality and GxP compliance with Vault QMS. With built-in best practices and automated workflows, Vault QMS brings all parties – pharma and biotech companies, contract manufacturers, and suppliers – into quality processes for better control and visibility. Easily bring departments, sites, suppliers, contract manufacturers, contract test labs, and other partners into continuous quality improvement processes. Increase operational efficiency with automated workflows and built-in best practices. Improve risk visibility across products and processes with a unified approach to risk management. Improve speed, efficiency, and GxP compliance with a unified suite of quality applications. Readily enable quality management processes with built-in best practices for deviation, internal and external audits, complaints, lab investigations, change control, CAPA, and quality risk management. -
19
CompliantPro
Siemens
CompliantPro Quality Management System Software is a tool that ensures a company’s quality assurance requirements are documented in a single, integrated system which demolishes silos of information managed as point solutions. CompliantPro allows an organization to manage its compliance and regulatory requirements beyond just document control. Key areas include Environmental Health & Safety, Enterprise Risk Management, Training & Qualifications, Audits, and customer / supplier management. -
20
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. -
21
TrackPro
TrackPro
TrackPro is a software solution that allows you to track and manage the status of recurrent activities such as calibrations, maintenance, and reminders. Tracking and controlling these activities will assist you in meeting the strict needs of today's highly regulated environment. TrackPro helps you meet the requirements of the QSR, cGMP, ISO 9000, QS 9000, ISO 13485, etc. Free for small companies allowing 100 entries. Integrated report designer. 31 integral report and label formats. Multilingual interface: Czech, Danish, Dutch, English, French, German, Italian, Norwegian, Polish, Portuguese, Spanish and Swedish. Single-user version fully compatible with Win 7, Win 8, Win 8.1 and Win 10. Multiuser version can be served from Microsoft Servers 2008, 2008 R2, 2012 R1, 2012 R2, 2016 2019. Audit trail capability. Dynamically created lookup lists that make the creation of each new item faster than the last. Automated email notification of custodians regarding items.Starting Price: $0.01 one-time payment -
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GageManager
ALTEGRA
GageManager is a fully-featured calibration management software from Altegra. With GageManager, service and repair facilities can ensure a fast, correct, and audit-compliant tracking and calibration of their equipment. GageManager's functionality covers inventory management, calibration scheduling, and measurement system analysis (MSA). It also comes with a dashboard-based screen design, giving users easy access to calibration status information. Our products include software for gage calibration management, at-machine job execution guidance, real-time predictive statistical process control, statistical quality control, and production decision support. Since 1999 our products have been helping manufacturing, industrial, and technical services companies increase productivity and profitability by avoiding unplanned downtime, reducing defects, and preventing equipment malfunction.Starting Price: $298 one-time payment -
23
CAPA Manager
Adaptive Business Management Systems
Automate the identification, containment, investigation, and resolution of problems within your organization and supply chain. Trusted by thousands of users globally, this is one of the best CAPA software applications available. CAPA Manager corrective action software automates the assignment, notification, investigation, reporting, and approval of corrective actions. It error-proofs the control of the entire CAPA process, from initiation to investigation and all the way through to closure. CAPA Manager meets the requirements of all important quality management standards: 21 CFR part 11, ISO 9001, AS9100, TS 16949, and more. It keeps records of root-cause and corrective action while providing pre-defined workflows and approval gates.Starting Price: $12.49 per user/month -
24
Qualipro
Saphir Consult
QUALIPRO is a management software of quality, environment, occupational health & security and food safety. Assistance, study and consulting quality, environment, health and safety at work, HACCP. Training and awareness-raising in the field of quality, environment, health and safety at work, food safety and audit techniques. Thanks to its setting flexibility and specific modules QUALIPRO responds perfectly to the expectations of the Pharmaceutical and medical devices industry. QUALIPRO is fulfilling the requirements of “Good Manufacturing Practices, GMP” and ISO13485 standards. QUALIPRO, Quality / SHEQ software, is aligned to major global standards including ISO 9001, EN 9100, ISO IATF 16949, ISO 14001, ISO 17025 and ISO 15189, ISO 22000, IFS, ISO 13485, ISO 27001, ISO 45001 standards. QUALIPRO is an innovative and modular software, it is an efficient tool for a Quality / QSE / SHEQ / SHE management system. -
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IMSXpress is a sophisticated document control, regulatory compliance, and quality system management platform used for operating ISO 13485 and FDA 21 CFR part 820 quality system that include document distribution, document control, CAPA, complaints, audits, training, MDR, supplier control, NC product, and more. Available as a local install or cloud data hosting, this cutting-edge software comes pre-loaded with template manuals and procedures, employee training booklets, and audit checklists.Starting Price: $1460.00/one-time
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26
Caliber v18
Dhruthi Technologies
Caliber v18 Improves the performance and effectiveness of your company’s gauge system by capturing and effortlessly generating Dues, status and trending analysis. Protects the company’s investment in measuring devices through disciplined tracking and proper maintenance. Saves time through quick look up and entry of multiple gages with minimal data entry. Reduces session time with efficient, user-friendly gage calibration software system. Ensures all quality requirements (ISO 9001; ISO13485; ISO 14001, ISO 17025, TS 16949; AS 9100; 21 CFR Part 11 and many more) are met or exceeded.Starting Price: $1000 one-time payment -
27
iPassport
Genial Genetic Solutions
iPassport is a managed software service designed specifically for healthcare laboratories to help digitize, streamline and improve the day to day management of quality and compliance. iPassport provides a complete suite of quality management modules, allowing you to easily keep on top of everything from document control to staff training. All your controlled documents stored in one place with appropriate access and edit permissions and full revision history. Everything you need to keep on top of internal and external audits. Record and manage NCs, CAPAs and incidents. Manage staff training and competencies, tasks, meetings and leave. A complete supplier database and audit tool including performance reviews. Manage and track assets and stock including equipment maintenance records. -
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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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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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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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QC-Pro Gage Control
Pister Group
Scheduling gage calibrations or verifications. Maintaining historical records of all activities. Measurement System Analysis (GRR, Stability, Bias, Linearity, Attribute Crosstab). Some of the key elements are record before/after readings across the operating range of the gage. Gage calibration schedule can be based on time interval or gage usage. Link external documents (e.g. calibration certificate) to a calibration record. Calibration procedure - free format steps to calibrate gage. Custom fields that are user defined. Data Security - option to restrict edits to existing calibration records. Audit Trail - maintains history of calibration record content prior to an edit. Reschedule gage calibration due dates that fall on holidays, weekends etc. Flexible report filtering (overdue, date range, gage id, location etc.) -
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Arena QMS
Arena, a PTC Business
Arena’s product-centric quality management system (QMS) software enables medical device manufacturers to deliver safe and compliant products to market fast. Arena QMS streamlines new product development and introduction (NPDI) by connecting quality and product processes. Arena QMS ensures regulatory compliance to various quality standards and regulations, including FDA 21 CFR Part 820, Part 11 and ISO 13485. Arena QMS enhances visibility and traceability by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans. -
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Q-Med Database
Sunday Business Systems
The Q-Med Database is an ISO 13485 compliant database to efficiently manage corrective and preventive actions, nonconformances, internal audit schedules and findings, safety improvement, supplier corrective actions, continual improvement projects. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Compile and analyze Customer Survey results. Document QMS review meetings and results. Cloud based or locally installed options are available. The Q-Med Database is ideal for small businesses striving for ISO 13485 compliance. CFR21 Part 11 compliant.Starting Price: $1900.00/one-time -
34
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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YunQuality
YunQuality Information Technology
Improve incoming parts quality and supplier quality performance,reduce the risk of production interruption, optimize the total cost of ownership, and manage supply chain risks. Monitor the in process quality performance and change of the trend through the whole flow of production, take preventive actions to reduce failure rate. Manage and control the quality of to-be-shipped out products, improve product competitiveness. Customer focus. Quick response to customer complaints, Improve the service and quality, improve customer satisfaction. Record and follow up corrective action and preventive actions.Realtime display of the task progress of each member.Enhance the capability of continuous improvement and improve corporate quality management system. Reduce the time on preparing audits, Improve the efficiency and effectiveness of audits. Mechanism in place to facilitate the audit as scheduled to be compliant with the requirements and regulations. -
36
Metaware QMS Platform
Metaware
Metaware.nl is a modern, scalable quality management software platform that helps organizations implement, manage and continuously improve their Quality Management System (QMS or GRC). The platform fully supports ISO 9001, ISO 14001, ISO 27001 and other international standards, enabling organizations to demonstrably comply with laws, regulations and certification requirements. Metaware centralizes document control, process management, risk management, incident and complaint management, CAPA, internal audits and management reviews in one secure, cloud-based sovereign solution. With real-time dashboards, workflow automation, role-based access and version control, organizations gain full control over quality, compliance and operational performance. Metaware reduces administrative burden, increases transparency and supports continuous improvement, making it suitable for both SMEs and enterprise-level organizations focused on professional quality assurance and compliance management.Starting Price: €142/month (Bronze) -
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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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GageList
GageList
UNLIMITED USERS on all accounts (including free). Free MULTI-SITE control panel. Free companion MOBILE APP for iOS and Android. Public API for integration with your enterprise applications. Trusted by major global industries, GageList supports compliance with ISO 9001, ISO 14001, ISO 17025, API Q1, AS 9100 and other standards. It's web-based so your unlimited users can access it anywhere, any time, on any device, and it's scalable to meet the needs of any organization. Nothing to install, and it's easy to learn and use. We also offer migration concierge service to help you migrate from your legacy system. GageList is FREE for up to 25 tools, and offers economical plans for every size of organization.Starting Price: Free -
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QualityPro by TecWork
TecWork Global Business Solutions Pvt. Ltd.
QualityPro by TecWork is a modern, 𝐞𝐧𝐭𝐞𝐫𝐩𝐫𝐢𝐬𝐞-𝐠𝐫𝐚𝐝𝐞 𝐰𝐞𝐛/𝐜𝐥𝐨𝐮𝐝-𝐛𝐚𝐬𝐞𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 (𝐐𝐌𝐒) designed to help manufacturing , automotive, and regulated organizations strengthen compliance, reduce operational risk, and build a proactive quality culture. Unlike traditional systems that only store documentation, 𝐐𝐮𝐚𝐥𝐢𝐭𝐲𝐏𝐫𝐨 𝐐𝐌𝐒 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 connects quality processes into one intelligent platform—ensuring clarity, accountability, and audit readiness across the entire organization. QualityPro centralizes critical QMS workflows including: ▶ Non-Conformance & Deviation Management ▶ Corrective and Preventive Actions (CAPA) ▶ Complaint Handling & Customer Quality Events ▶ Audit Planning & Execution ▶ Calibration & Equipment Management ▶ Inspection & Quality Control ▶ Document Control ▶ Training Management & Competency Tracking ▶ Risk Management & Continuous Improvement ▶ Change ManagementStarting Price: Contact us for pricing -
40
Asset Tracking Database
Sunday Business Systems
The best value in CALIBRATION MANAGEMENT Software. Record calibration / validation history. Document internal calibration measurement values and generate calibration certificates. Document responses when measuring equipment is found to be unfit for its intended purpose. . Generate a Recall Report for “Out of Cal” Equipment, manage the recall schedule and review detailed calibration reports. Create Preventive Maintenance Schedules. Define Preventive Maintenance Checklists. Track Unscheduled Maintenance. Generate Fix-It-Tickets. Control Miscellaneous Assets. Rich set of reports for detailed analysis. Easily generate a Calibration Recall report. Maintenance Due reports show the status of your equipment with a click of a button. Scan and link digital photographs, calibration certificates, or other electronic documents. A Vital Tool to ensure QMS compliance to ISO 9001, AS9100, ISO 13485, etc. Cloud-based or on premise solutions are available.Starting Price: $249 one-time payment -
41
Merit for Life Science
Merit Solutions
Cloud-first ERP is intentionally tailored for life science organizations. Merit for Life Science is cloud-first ERP purposely built for biotech, pharma, and medical device manufacturers. It advances Dynamics 365 finance and operations to connect your entire organization. Mapping resource qualifications to production requirements. Monitoring vendor relationships in procurement to help ensure quality standards are met in manufacturing. Providing your life science organization with visibility and transparency to deliver safe, innovative products and much more. Your organization has unique needs and we understand them. Get the full picture of what we offer. Delivering an industry-tailored solution that meets the rigorous requirements of pharma, biotech, and medical device companies. Improve your decision-making process with reliable, auditable accounting practices. Establish financial reporting standards for acquired entities or prepare for acquisition. -
42
Calibrate
Ambrit
High integrity measurement and control systems need to be carefully calibrated to ensure each instrument is working within its operational limits. Calibrate™ manages the whole calibration process and provides certification that can be easily accessed and audited. Gone are the days of storing calibrations in many separate spreadsheets scattered over several different machines. Calibrate™ is an online metering calibration management system that is designed to streamline the calibration process in one centrally managed database that maintains an auditable trail of all calibrations that have been performed. One or more calibrations can be defined for every piece of equipment in the database using templates from Calibrate™’s extensive library of available metering calculations. These templates dynamically adjust to reflect the type of form required as options and other parameters are defined. -
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Sirwill FBM Tools
Sirwill Software
Designed and validated by our SPC / Six Sigma consultants, this is one of the most versatile and economical software for analyzing statistical process control (SPC) data. It can also compute the six sigma process metrics as well as predict the process average for Engineering Process Control (EPC). A must for all organizations and students pursuing Six Sigma. Our management consultants have vast experience in successfully implementing ISO9001:2015 / ISO14001:2015 / ISO17025:2017 / ISO22000:2018 / ISO27001:2013 / ISO45001:2018 / ISO50001:2018 / SA8000:2014 Management Systems at various client organisations around the world. On the basis of their experience, our consultants have prepared step-by-step system implementation guidelines that provide clear directions to managers (management representatives) who would plan and implement the system. Following these guidelines could cut down the cost and duration of your project substantially.Starting Price: $85 one-time payment -
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ProCal
TMA Systems
ProCal by TMA Systems is an enterprise-grade calibration management software designed to replace paper-based processes with efficient, digital workflows. It helps organizations maintain precision, compliance, and consistency across calibration programs of any scale. ProCal automates calculations, applies tolerances, and instantly flags pass or fail results to minimize human error. The platform generates audit-ready records, certificates, and complete calibration histories to simplify inspections and regulatory reviews. Built for ISO, GMP, FDA, and 21 CFR Part 11 compliance, it supports secure access, electronic signatures, and approval controls. ProCal scales easily from single departments to global enterprises with multi-account and multi-language support. Trusted by leading manufacturers, it delivers a streamlined, paperless approach to calibration management. -
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Metrolog X4
Metrologic Group
Metrolog X4 is an advanced 3D metrology software designed to redefine quality control and measurement standards across industries. It optimizes the entire measurement process using high-performance algorithms and fast calculation speeds. The platform delivers reliable, repeatable, and highly accurate 3D measurement results. Metrolog X4 supports full automation of inspection, analysis, and reporting to improve productivity. Its universal compatibility allows seamless use with all major 3D measuring equipment, including CMMs, laser trackers, and scanners. Advanced GD&T analysis ensures compliance with ANSI and ISO standards. Metrolog X4 enables manufacturers to achieve superior quality control performance at scale. -
46
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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xTrak
usCalibration
A one-stop shop. You won’t need to utilize several calibration vendors. Calibration, Repair, and New Equipment Sales to manage asset life cycle. Most onsite calibration capabilities in Southern California. Nobody beats us. Certificates are created by technicians on the spot. No waiting for certificates. Expert, quality service in the calibration of all major equipment types. Focus on Customer Service: You will always get quick responses from us. Weekly pick up delivery is offered for Southern California. Use our Cloud Calibration Management xTrak on a tablet or PC. 6 consecutive years of zero deficiencies in A2LA ISO Audits. Serving Aerospace, Medical, Automotive, Electronic, Energy sectors since 1997. xTrak® is a cloud-based calibration management system. Calibration records and statuses are automatically updated after each service. Reduce the time needed to manage calibration so that you can focus on your core business. -
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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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Nova-CPM
Novatek International
Novatek International offers comprehensive software solutions that meets and exceeds the quality and compliance requirements for the life science industry. The process-specific offerings are an integrated platform that provides consistency and standardization across multiple departments within a site, and across multiple sites. This greatly reduces the total cost of ownership and results in a higher ROI. NOVA-CPM is a state-of-the-art automation tool that provides full management of your equipment qualification, calibration, and maintenance processes. The system is designed to ensure global regulatory compliance and data integrity, with security and electronic signature and audit trails. NOVA-CPM is the leading Computerized Maintenance Management System (CMMS) solution that provides functionality for the full life cycle of equipment, from purchase and validation, calibration and maintenance operations, repairs, and end-of-life replacement. -
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Database Providers Calibration Management Software
Database Providers
Manage all measuring devices used within your organization using our simple, effective and efficient solution. Our solution includes a flexible and scalable approach to identifying, establishing calibration requirements, and communicating the status of all measuring devices/equipment/tools within the Calibration system. A quick and easy method for recording the successful calibration of each tool and the extension of the next due date. Scheduling of calibration is made easy using a calendar view of measuring devices’ calibration due dates. Our solution provides for automated emails to identify and communicate measuring devices whose calibration is past due, or due within the next 30 or 60 days; which has proven to increase the effectiveness of calibration programs. When used in conjunction with ISO 9001-based compliant calibration programs, this Calibrations Management Software provides for all required information, documentation and records.
