Alternatives to QM
Compare QM alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to QM in 2026. Compare features, ratings, user reviews, pricing, and more from QM competitors and alternatives in order to make an informed decision for your business.
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HSI Donesafe
Donesafe
HSI Donesafe is a no-code, cloud-based EHS software that simplifies safety, compliance, and risk management, transforming complex processes into user-friendly workflows. Trusted by industries worldwide, Donesafe allows organizations to track, manage, and report on essential EHS functions from one central platform. Our software adapts to your team’s style, enhancing everyday workflows with effortless compliance and smooth operations. Keep pace with evolving regulations and standards, from incident reporting and audits to training and risk assessments with Donesafe. Unlock peace of mind with: - Workflows that flex to meet ever-changing regulations - Instant insights, keeping you confident in real-time safety tracking - A scalable platform that grows in step with your team’s journey - Simplified compliance that makes audits and reporting a breeze Put safety at the heart of every day with HSI Donesafe; protect your team, simplify compliance, and ensure everyone goes home safe. -
2
Process Street
Process Street
Process Street is an AI-powered compliance operations platform that automates complex workflows, enforces standards, and tracks audit data in real time. Teams use it to create structured SOPs, assign tasks, collect data, and monitor execution with intelligent oversight. From onboarding and audits to vendor management and document control, Process Street ensures every step is followed and every action is logged. Built for regulated industries like financial services, healthcare, and manufacturing, it supports frameworks such as ISO, SOC 2, SOX, and HIPAA. With role-based permissions, audit logs, and powerful integrations, Process Street replaces static documents, spreadsheets, and manual processes with a single automated system of record. Use AI to streamline approvals, catch risks early, and generate audit-ready evidence. Trusted by teams at Cargill, DoorDash, Farmers Insurance, and Hartford Healthcare. -
3
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 -
4
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. -
5
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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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 -
7
Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
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SimplerQMS
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.Starting Price: $13,750/year -
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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 -
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ARMATURE Fabric
ARMATURE
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 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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Qualcy QMS
Qualcy Systems
Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.Starting Price: $799 per month -
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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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ZenQMS
ZenQMS
ZenQMS is an AI-enabled electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO companies. The cloud-based, fully validated platform supports document control, training management, audits, supplier management, CAPA management, quality data intelligence, and compliance with FDA 21 CFR Part 11 and ISO standards. Unlike legacy systems, ZenQMS is designed for companies of all sizes to be easier to use, quicker to validate, and more effective at managing GxP activities. ZenQMS supports key quality processes, including: Document management/document control Training management and learning management CAPAs (Corrective and Preventive Actions) Deviations, nonconformances, complaints, issues, and other quality events Change controls Audit management Supplier and vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting -
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qmsWrapper
qmsWrapper
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. Document Control: Intuitively manage documents for enhanced traceability and version control. Cloud-Based Accessibility: Access your QMS anytime, anywhere. Electronic QMS: Embrace efficiency with digitized QMS for faster approvals and real-time updates. Audit Management: Prepare for audits confidently with scheduling, tracking, and reporting tools.Starting Price: $500/month/10 users -
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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 NotificationsStarting Price: $500 one-time payment -
18
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. -
20
Harrington Quality Management Software (HQMS)
Harrington Group International
HQMS' applications include Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. In business since 1991 – trustworthy source with SME Experts in Sales and Support will help with Business Case, Flexibility (on-premise or hosted, CapEx and Opex pricing models) with Support and Training & deployment planning that provides rapid learning curve with implementation guides. Secure deployment – including Single Sign On (SSO). Configuration and personalization features with customization if needed. HQMS is used cross several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.Starting Price: $500/month -
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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 -
22
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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TraxQM
TraxQM
TraxQM is a risk-based Quality Management System (QMS) designed to help organizations manage regulatory compliance, streamline quality processes, and improve operational efficiency through a centralized, AI-enhanced platform. It enables companies to take a proactive approach to compliance by digitizing workflows and applying structured methodologies aligned with international standards such as ISO and GxP. It includes core modules for document management, risk analysis, CAPA (Corrective and Preventive Actions), change control, audits, and training, allowing teams to manage the full lifecycle of quality operations in one system. It supports data integrity through automated version control, audit trails, and compliant electronic signatures, ensuring traceability and adherence to regulatory requirements. TraxQM leverages AI to enhance decision-making by analyzing risks, suggesting targeted control measures, and recommending relevant KPIs based on organizational objectives.Starting Price: $403.97 per month -
24
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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Veeva Vault QualityDocs
Veeva Systems
Providing automated workflows and comprehensive audit trails, Vault QualityDocs reduces compliance risk and improves quality processes. It accelerates review and approval processes and facilitates the sharing of SOPs and other GxP documents among employees and partners. Automated workflows and visibility into the content status and processes enable effective SOP management, reducing compliance risk. Intuitive, easy-to-use user interface drives adoption and efficiency. Detailed audit trails, content organization, and powerful search facilitate better audits and inspections. Securely access and use documents from any major web browser, or if enabled, print, distribute, and track controlled PDF copies. Predefined document taxonomy, metadata, and pick lists for quality, manufacturing, and validation documents facilitate operational harmonization and allow organizations to quickly adopt best practices. -
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Carizma QM
Axicos
Carizma QM is a web-based software that supports users in managing the entire lifecycle of regulated documents from authoring, review, approval and release to archiving. Creation and management of regulated documents, e.g. SOPs. Integrated workflows for review and approval. Automatic start of training workflow, read and understood upon approval. Electronic signature – 21 CRF part 11 compliant. Display of users who have read and understood. Validated and audit trail. Supports users to manage the entire lifecycle of regulated documents within Carizma-QM itself. The author defines key information e.g. document type (SOP, work instruction, form, checklist, etc.), title of document, process owner (department), groups of users to whom the document is applicable, review cycle. Users are defined in due time by e-mail when a document needs to be reviewed. Carizma creates the skeleton document. -
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Validfor
Validfor
Validfor is a secure, modular digital validation platform that centralizes the entire validation lifecycle on a single, paperless system. Designed specifically for regulated industries, Validfor enables efficient validation while ensuring full compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The platform supports electronic records and advanced electronic signatures with full audit trails, role-based workflows (Author, Reviewer, Approver), and complete CSV compliance. All documents and records are securely managed in a centralized repository, capturing every change with full traceability to protect data integrity and Quality Assurance. Validfor offers integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, enabling seamless impact assessments, CAPA tracking, Computer Software Assurance (CSA), and audit-ready lifecycle management. -
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Almond
Almond
Almond is a professional, cloud-based, quality management software for healthcare companies. The software enables computerized management of the quality processes in compliance with regulatory requirements. The system maintains a document audit trail, and full document indexing and ultimately achieves documented evidence of all QMS processes. Manage your suppliers seamlessly through the electronic organization of certificates and agreements; all information is concentrated in one place. Assign permission to your suppliers to perform training, required by your system at their premises, using your quality system. Receive automatic email notifications before supplier certification expires. An electronic control dashboard allows you to be updated at any time on the status of the project. Create as many logbooks as you need, with no budget considerations or storage restrictions. Automatic conversion to effective after training completion. -
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iPassport
Genial Genetic Solutions
iPassport is a managed software service designed specifically for healthcare laboratories to help digitize, streamline and improve the day to day management of quality and compliance. iPassport provides a complete suite of quality management modules, allowing you to easily keep on top of everything from document control to staff training. All your controlled documents stored in one place with appropriate access and edit permissions and full revision history. Everything you need to keep on top of internal and external audits. Record and manage NCs, CAPAs and incidents. Manage staff training and competencies, tasks, meetings and leave. A complete supplier database and audit tool including performance reviews. Manage and track assets and stock including equipment maintenance records. -
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Clinevo OneQMS
Clinevo
Clinevo OneQMS is a cloud-based quality management system that enables organizations to manage quality and compliance processes digitally. Clinevo OneQMS is an interactive platform to manage all quality and compliance processes of an organization. OneQMS enables organizations to manage documents, training, change, CAPA, and audits in one place. It can be accessed with basic internet/intranet using IE, Chrome, and Firefox browsers. Provides powerful and actionable dashboards and reports for real-time monitoring and tracking of quality and compliance. Business, quality, IT teams, and others can be trained on the Clinevo within a few hours. Clinevo OneQMS complies with all current and emerging regulations. It ships with an inbuilt training management system to efficiently manage the organization’s training processes. It is the best QMS software and comes with transparent optimized pricing. -
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Wismatix QMS
Wismatix
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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CSols AqcTools
CSols
CSols AqcTools™ v2.6 allows users to dynamically display Analytical Quality Control (AQC) charts to monitor lab performance, provides paper-free, auditable investigations of control limit failures, includes comprehensive reports and reduces the time to assess and process your QC data. Customers in water, environmental, public health sector and industrial laboratories undertaking chemical, clinical and microbiological analysis will benefit from AqcTools. It provides a selection of ‘dynamic, interactive’ charts from the standard ‘individual plotted AQC points’ to charts that can use batch or daily means of data, for both current and historic data. In addition, users can plot charts for an individual analyst to support the labs on-going analyst competency checking. All of the information relating to each individual point such as date, batch number, analyst, instrument etc. is just one mouse click away. -
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Certdox
Certdox
Certdox is food safety management software built for the real work of FSQA teams. It replaces spreadsheets, binders, and scattered files with a clear, centralized system that tracks documents, training, audits, and supplier compliance. Designed by professionals with firsthand food industry experience, Certdox helps manufacturers stay organized, accountable, and audit-ready every day, not just audit day. The platform includes all modules for one flat price and supports unlimited users per facility. With simple onboarding, built-in templates, and secure cloud access, Certdox fits into your daily operations without getting in the way. Whether you are preparing for GFSI certification or managing HACCP programs across sites, Certdox gives your team clarity, control, and confidence. -
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AmpleLogic APQR
AmpleLogic
Introducing AmpleLogic AI-based APQR software, a revolutionary solution that helps you generate accurate Product Quality Review (PQR) reports and CPV reports for audits and regulatory submissions as per the current Good Manufacturing Practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). With OCR data extraction and AI chatbot integration, AmpleLogic APQR solution streamlines document data extraction and quickens access to information, boosting audit readiness and operational efficiency. -
35
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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ins2outs
ins2outs
ins2outs is a cloud-based SaaS integrated compliance management platform that empowers organizations to define, operate, and maintain multiple management systems, such as quality, information security, privacy, environment, and AI, within a single unified environment by combining powerful software, pre-built “know-how” sets mapped to standards like ISO 13485/21 CFR 820, ISO 27001, ISO 27701, IEC 62304, and ISO 42001, and expert consulting services. It helps organizations build structured documentation, including policies, processes, procedures, instructions, and document templates, and manage workflows with automated role-based training, push notifications, compliance KPIs, configurable documentation logic, version control, and audit trails, all hosted securely in the cloud. Users can operate integrated systems that address multiple regulatory and standard requirements, manage electronic documentation collaboratively with traceability and export options.Starting Price: $25 per month -
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TrackWise
Honeywell International
Honeywell's TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to help organizations efficiently manage quality and compliance processes. Leveraging nearly three decades of industry experience, it offers integrated modules that support various quality management aspects, including document control, training management, and corrective and preventive actions (CAPA). The platform incorporates advanced digital technologies such as artificial intelligence and machine learning to provide actionable, real-time insights, enabling proactive quality management. Its flexible, modular architecture allows for seamless integration with existing enterprise systems, facilitating rapid deployment and scalability. By streamlining quality processes and ensuring compliance with industry standards, TrackWise Digital® empowers organizations to bring products to market faster while minimizing risk.Starting Price: $200 per month -
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Audit Manager
Focus Informatica
Audit Manager is the software supporting quality management that allows digital management of audits, quality controls and tests in all their phases: planning and compilation through checklists, collection of evidence and field surveys, verification and management of the entire nonconformity flow, definition of corrective actions and data monitoring. Access the calendar and schedule the audits by associating the relevant information with each one (subject, checklist, lead auditor, co-auditor, participants, etc.). The staff involved, both internal and external, can receive an invitation via email and consult the prepared audit schedule directly from the app. Once the inspection is completed, generate the audit report in PDF or Excel and share it directly from mobile with the company management or managers. The archive of all minutes is always available and organized and you can add it to the document repositories used by the company. -
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IMSXpress ISO 9001
IMSXpress
IMSXpress ISO 9001 is a document control and quality system management software. The IMSXpress client application can be installed directly on user computers, or on a Windows server and then be distributed to users by remote desktop services as a remote application. The database is an MS SQL database. It can be installed on any MS SQL Server 2014 or higher and be accessed by the IMSXpress application over any type of network. You can set up your own remote access, use our cloud-based data hosting service, or get the online subscription package. Fully automated training system with self-training, integrated document training, job descriptions, and more. Use for document, engineering, and process changes. Make fillable PDF form templates, fill the forms with data, and create records. Use for scheduling and administrating maintenance, and for managing spare parts inventory. Manage complaints, non-conformities, risk management, audit findings, and more.Starting Price: $160 per month -
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Ideagen Qadex
QADEX
Food Safety Software enabling cost-effective transformation of food safety, NPD, customer complaints and supply chain transparency. Save time and complete consistent, auditable risk assessments of products & suppliers; our food safety software includes horizon scanning and VACCP/TACCP. Be audit-ready 24/7 and never receive an audit non-conformance, guaranteed. Transform specification management for raw materials, and finished products and answer product queries instantly. Automate supplier quality monitoring or internal non-conformance management with automated workflows to ensure prompt closure of non-conformances. Let our team manage the entire complaints process using market-leading software to save time, money and improve customer service. Deliver new product launches faster, better, together while ensuring that all safety, quality, legality and profitability requirements are met. -
41
DocsTrail
Arccus Inc
DocsTrail is an all-in-one e-signature software and digital document workflow solution designed to streamline electronic signing and document processes for modern teams. Users can quickly prepare, send, and sign contracts, agreements, and files securely from any device. Features include secure encrypted signing, automated reminders, multi-signer workflows, full audit trails, real-time status tracking, and integration with existing tools. The platform supports various document formats including PDF, Word, and images. DocsTrail enables businesses in HR, real estate, education, and other sectors to improve productivity, compliance, and document control.Starting Price: $14.99/month -
42
Trevally
ManualMaster
Trevally is ManualMaster’s next-generation QHSE platform covering the full PDCA loop. In one web or on-prem environment it delivers controlled document and version management with audit trails, process mapping, risk and standard control, QA registrations and smart web forms. Extra modules handle incidents, complaints, audits, deviations, tasks and actions, all surfaced in a role-based dashboard with live KPIs, reports and graphs. ISO-27001 hosting, backups, SSO, 2-factor login and granular rights protect data; multi-language UI, digital signatures and mobile access boost adoption. An open REST API plus the 2024 Certifeye connector imports supplier certificates automatically. Q-Learning, alerts and automated workflows drive continual improvement, while flexible cloud or server licensing keeps change agile yet traceable.Starting Price: $6000/year -
43
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. -
44
Ennov Quality Suite
Ennov
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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JetSign
JetSign
Tap or click anywhere to sign with your finger. Add your e-signature, dates, and text to your document and generate a signed PDF! Send out documents for e-signature with a simple signing link that you can share in your own email or text message. You and your remote signer(s) can view and sign your document with a full audit trail. Easily fill and sign forms by editing text directly on the document - no text entry pop-ups required! Resize text, add checkmarks and X's, and clone fields with our form filler features and save as a PDF. Add one or several documents at a time including Word (doc/docx), Pages, PDF, HTML, RTF, WordPerfect, images, and 15 other file formats. We protect your documents in the cloud with leading encryption methods (AES-256), SSL hosting, and full audit trails for electronic signatures.Starting Price: Free -
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AutoSHEQ
AutoSHEQ Solutions
Convert your time consuming paper driven management system into a cost effective paperless environment. The Documentation module provides the means to manage the review, modification, approval, distribution and accessibility of your documentation. Record and manage problems that are caused by imperfections in products, services or systems of your organization. Identify how your data will be reported by grouping problems according to your own defined regions, services, product types, processes and related risks. Create a schedule for Internal audits and for supplier audits in the software. Allocate responsibilities and link any audit findings to the planned audits. Schedule calibration and or maintenance tasks on a rolling basis as per set frequency that you specify. Task records and any attachments to the task records are retained in the software. This module is provided as complementary.Starting Price: $255 per month -
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Lyons Quality Audit Tracking LQATS
Lyons Information Systems
Lyons Quality Audit Tracking System (LQATS)® is a robust, flexible, web-based solution to gather, analyze and display quality audit results generated by staff and suppliers of a manufacturing organization. LQATS gathers real time audit information worldwide from: Suppliers (shipment audits) Company auditors (final audits) Distribution centers Manufacturing plants LQATS provides real-time entry, tracking, and analysis of quality audit data from Distribution Centers and Supplier plant locations. Features include: "Smart controls" to minimize user data entry and retrieval tasks Change History tracking Quick search of data using many different query parameters Real-time global performance monitor Fabric Inspections Six-sigma analysis Disposition log Data displayed in both tabular and graphical formats with output to Excel, PDF, format -
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Intact Platform
Intact
The Intact Platform is the leading cloud and on-premise Enterprise Resource Planning (ERP) solution for audits, assessments, certification, accreditation, and standards worldwide. It goes beyond other audit collection tools on the market with a full solution approach that helps you manage communications, business goals, and personnel. The Intact Platform is unsurpassed in functionality and features a fully modular end-to-end workflow that is easily scalable. ✓ 34% increase in efficiency on average (up to 60+%) ✓ Unmatched modularity, flexibility, and scalability ✓ All standards and audit services ✓ Digital workflow – no paper ✓ On-site and remote auditing ✓ Non-conformities & corrective actions ✓ Risk-based auditing & planning ✓ Easy client communication ✓ Reporting & business intelligence (BI) ✓ Central data and management hub (incl. full audit trail) ✓ Nonstop innovationStarting Price: On request -
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QualityKick
SoftDoit
QualityKick is a QMS compliance solution in the cloud for quality management of the biological sciences. It consists of different modules; each of them solves a specific part of the quality management processes: document control, training, change control, events, CAPA, risk assessment, qualification, and audits of suppliers and equipment. As it is a web-based application, it can be accessed from anywhere and from any device mobile. Works everywhere: computer, smartphone, and tablet. Guided tour which loads automatically when new users log in for the first time. Allows you to edit documents with MS Word and send them through a configurable review and approval process. Different types of events can be configured such as deviations, nonconformities, or complaints. It is possible to define CAPA plans, record the actions, and verify their effectiveness. Solutions for quality management in the pharmacy, biotechnology, and medicine sectors. -
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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
