Alternatives to Clearlane CAPA
Compare Clearlane CAPA alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Clearlane CAPA in 2026. Compare features, ratings, user reviews, pricing, and more from Clearlane CAPA competitors and alternatives in order to make an informed decision for your business.
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AlisQI
AlisQI
AlisQI is a modular, cloud-based Quality Management platform for process and batch manufacturers who want to reduce firefighting, improve predictability, and stay compliant by default. Unlike traditional EQMS platforms that were built around documents and later adapted for analytics, AlisQI was designed from the start as a data-first system. Quality, lab, and production data are structured and connected in one operational backbone. That foundation now enables practical AI capabilities inside daily workflows. Manufacturers can automatically extract data from diverse supplier COAs without predefined templates, generate structured digital forms from existing files or plain language, query their QMS conversationally, and detect recurring incident patterns across sites. Core modules include Document Control, Training, Deviations, CAPA, Audits, Risk Management, Supplier Quality, SPC, and EHS, supported by targeted out-of-the-box Solvers that address specific operational problems. -
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isoTracker Quality Management
isoTracker Solutions Ltd
isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it. It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management. It can be configured to meet an organization's specific needs and provides free training and free support. It has been independently judged to provide the best customer support in its category. -
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SBS Quality Management Software
Sunday Business Systems
Affordable QMS Software for Small and Midsize Organizations The SBS QMS Suite is an integrated Quality Management System (QMS) software solution designed to help small and midsize manufacturers and other quality-driven organizations efficiently manage ISO 9001 and related quality requirements. Five specialized modules provide document control, employee training, CAPA and nonconformance management, audits, risk management, calibration, preventive maintenance, supplier management, inspection and SPC. SBS QMS Software is available as a cloud-based or locally installed solution and uses flexible concurrent-user licensing. Organizations may implement the complete QMS Suite or purchase individual modules to fit their quality system requirements and budget. Professional QMS capabilities without the enterprise price tag. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - Environmental Health and Safety (EHS) module SBS Ground Control - Employee training management (LMS) - Document control - Change 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 For a small or midsize manufacturer seeking ISO 9001 QMS functionality without enterprise-level cost and complexity, SBS QMS Suite is an option worth considering. -
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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 -
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Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
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SimplerQMS
SimplerQMS
SimplerQMS is an electronic quality management system (eQMS) built by life science experts. It helps life science companies stay compliant with FDA, ISO, and GxP requirements while reducing manual work and improving audit readiness. With SimplerQMS, teams can easily manage documents, change control, training, CAPA, analytics, and more on one cloud-based platform. The system is fully validated, so companies can start quickly without a long validation process. What customers appreciate most: • Compliant processes and fewer manual errors • Fast implementation and smooth data migration • User training and 24/7 global support • Guidance from compliance experts throughout the journey Whether you're a growing startup or an established life science company, SimplerQMS gives you the tools and support to build a strong quality culture and stay audit-ready every day.Starting Price: $17,500 / year -
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TenForce
TenForce
Track, analyze and report on your EHSQ processes from a single platform. Automate workflows, centralize data and simplifiy collaboration across departments. TenForce offers various integrated modules to help streamline processes such as Audits, Incident Management, CAPA, Permit to Work, Management of Change, and Shift Management. It offers mobile capabilities, which allow field workers and inspectors to access the software on mobile devices. Its built-in data analytics and reporting functionality enables managers to gain insights into the processes and risks of their industrial plants or public infrastructure assets. This visibility helps them address environmental, health, safety, quality, and compliance issues. TenForce helps manufacturers optimize their established processes while minimizing incidents.Starting Price: $9000 per year -
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Sunday Business Systems
Sunday Business Systems
Sunday Business Systems (SBS) offers comprehensive quality management software (QMS) and consulting services to improve compliance with quality management standards, including ISO 9001, AS9100, ISO 14001, ISO 45001, and ISO 13485. Our solutions, such as Corrective Action and Preventive Action (CAPA) management, document control, and employee training management, help businesses streamline operations while ensuring compliance with industry regulations. SBS provides software tools for a full rangce of systems including audit management, calibration control, Preventive maintenance, EHS tracking, vendor management and inspection data collection and statistical process control (SPC). SBS provides on-premise and cloud-based solutions and customized software tailored to the unique needs of small businesses, improving productivity and operational efficiency. SBS offers the best value in QMS software.Starting Price: $295 -
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Qualityze EQMS Suite
Qualityze
Qualityze is a leading provider of cloud-based Quality Management System (QMS) and Enterprise Quality Management Software (EQMS) solutions built natively on the Salesforce platform. Designed to streamline quality processes, ensure regulatory compliance, and drive operational excellence, Qualityze empowers organizations to manage CAPA, audits, document control, training, change management, risk management, and supplier quality within a unified, scalable ecosystem. Focused exclusively on quality and compliance, Qualityze delivers purpose-built QMS and EQMS solutions without distractions from unrelated custom development. Our platform enables organizations across life sciences, manufacturing, and other regulated industries to simplify compliance with global standards while improving visibility, traceability, and accountability. Qualityze fosters a true culture of quality by making enterprise quality management intuitive, user-friendly, and collaborative.Starting Price: $30/User/Month -
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BPAQuality365
BPA Solutions
BPAQuality365 is a prebuilt QMS software to use in your secured Microsoft 365 cloud, leveraging tools used by collaborators daily, with no need to change user habits. It’s modern, compliant with any device, flexible to match your unique needs, and powered by innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, risk, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app is closely integrated to discussion flows in Teams and enable instant quality improvement. Go a step further and reach your Quality 4.0 objectives by combining powerful AI features, best-in-class workflow automation, business intelligence and mobile Power Apps to run on any device. Benefit from BPA’s Microsoft Preferred status to configure your QMS to your needs, transfer knowledge to your power users and get trained on M365 technologies. -
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QT9 QMS
QT9 Software
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business. Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%. With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management. Start your free trial or book a personalized demo today.Starting Price: $10,000/year -
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Artintech ERP
Artintech
Artintech ERP is a comprehensive enterprise resource planning solution designed to optimize and streamline your business operations across various departments. Tailored for small to medium-sized enterprises (SMEs), Artintech ERP offers robust functionality with a user-friendly interface, allowing businesses to seamlessly manage their resources, inventory, human capital, finances, and customer relations all in one integrated platform. Artintech ERP includes a wide range of modules designed to optimize business operations. Key modules include Procurement, Warehousing, CRM, Distribution, Quality Management (QMS), Workplace Safety, Document Control, Non-Conformance and Corrective and Preventive Actions (CAPA), Inspection, and Computerized Maintenance Management System (CMMS).Starting Price: $24.95/Module/Month -
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Qualcy QMS
Qualcy Systems
Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.Starting Price: $799 per month -
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CAPA Manager
Adaptive Business Management Systems
Free CAPA Software — 2 Users, No Time Limit! No credit card, no setup fees, and no sales calls. Get instant access to professional corrective and preventive action software. Free accounts are subject to our terms of service and inactivity policy. CAPA Manager helps aerospace, automotive, medical device, pharmaceutical, and manufacturing organizations investigate problems, identify root causes, and manage corrective actions. Features include configurable 8D, A3, DMAIC, and PDCA workflows, integrated 5 Why and 6M analysis, action tracking, closure approvals, audit trails, digital signatures, interactive dashboards, and reporting. Optional API integration and Single Sign-On (SSO) support growing organizations. Start FREE with two users and upgrade whenever you're ready.Starting Price: $18.21 per user/month -
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IQE is MediaLab’s non-conforming event management system that allows clinical laboratory teams to track, assess, and prevent non-conforming events (NCE). With the capability to import or create event forms and data logs, IQE enables laboratory teams to eliminate deficiencies, correct common NCEs, and, most importantly, focus on improving healthcare. With a MediaLab institutional subscription, administrators can easily document each phase of the event management lifecycle, from initial event description to risk analysis, investigation, and root cause analysis, corrective and preventive actions plans, and overall CAPA effectiveness evaluations. IQE supports: • Customizable, pre-built event forms and workflow • Monitoring and evaluating change control events, failed PT events, customer complaints / feedback, safety / injury events, supplier / vendor issues, and more • Tracking periodic data entries • Robust reporting and dashboards to identify common NCEs and CAPA effectiveness
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Grand Avenue Software
Grand Avenue Software
A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed. -
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SolvoNext NCR CAPA
ORCA LEAN
SolvoNext – NCR CAPA is a manufacturing software designed to digitize non-conformance reporting (NCR) and corrective & preventive actions (CAPA), reducing the cost of poor quality. It streamlines documentation and collaboration for production, quality, and other teams with an easy-to-follow, four-step process that includes initiation, root cause analysis, financial tracking, and approval. The platform replaces manual, paper-driven processes with visual dashboards, automated charts, and real-time reports, eliminating human errors from spreadsheets. It also supports COPQ tracking, enabling factories to calculate and monitor the financial impact of quality issues and inefficiencies. Users benefit from built-in tools like 5 Whys and Fishbone analysis, role-based access, and automated notifications. With optional AI integration, SolvoNext provides advanced analytics, pattern recognition, and decision-making insights for smarter manufacturing operations. -
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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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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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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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SBS Quality Database
Sunday Business Systems
The SBS Quality Database is a simple, inexpensive, ISO 9001 compliant software program that allows small businesses to efficiency manage the Quality Management System or QMS. The database tracks corrective actions, preventive actions (CAPA), internal audits, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Document interested parties as part of the Context of the organization. Use the dashboard for a quick view of the overall performance. Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001:2015, API Q1, AS9100, or TS16949 compliance. Free demo downloads are available from our website so you may try before your buy.Starting Price: $499/one-time -
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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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IONI
ioni.ai
IONI is an AI agent platform for food and beverage compliance and operations - built for manufacturers, co-packers, brands, and ingredient suppliers worldwide. Most food safety software makes you build everything from scratch. IONI does the opposite: upload your existing SOPs, recipes, and HACCP plans: AI agents read them and automatically build your complete compliance system. What you get: - Auto-generated HACCP plan (any standard: SQF, BRCGS, FSMA, CFIA, FSSC 22000, and others) - Digital operator checklists on tablet or phone - no training needed - Supplier certificate tracker with automatic expiry alerts - AI CAPA automation - root-cause analysis drafted on every deviation - Real-time deviation alerts for QA managers - One-click audit report for any standard or retailer requirement Works for manufacturers, co-packers, brands, and ingredient suppliers. Available globally. Onboarding: every client gets a personal 30-minute setup call.Starting Price: $1000-1200/year -
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FactoryQA
FactoryQA
FactoryQA is an all-in-one Quality Management software for Manufacturers. Software Features: 1. Non-Conformance/CAPA Management 2. Document Control 3. Work Instructions 4. Inspection Sheets 5. Audits 6. Analytics Services: 1. ISO Certification Consultants 2. ISO Certification Workshops 3. Fractional Quality Management ServicesStarting Price: $1200 per year -
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ProActive QMS
ProActive QMS
ISO and BRC compliance software meet the requirements of multiple management standards including ISO 9001, 14001, ISO 45001, ISO 27001, and the BRC standards. Intuitive powerful CAPA software, capturing continual improvement activities, non-conformities, root cause analysis, corrective and preventive actions, and top loss performance data. Effective version and change controls for system documents and controlled forms. Location issue controls for user access to role-related documents only. Compliance evaluation software listing compliance requirements, departmental/area accountability, guidance on legal and other requirements conformity for single or multiple standards including ISO 9001, ISO 14001, ISO 45001, ISO 27001, etc. Supplier, service provider, and contractor qualification, ongoing assessment, and performance enhancement made easy through customized risk work streams, assessments, software scheduled re-assessments, and targeted action logs.Starting Price: $150.95 per month -
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ExtraView
ExtraView
ExtraView is an enterprise software platform implementing business process management, global quality management systems for CAPA, adverse event reporting, food safety, bug and defect tracking, change management, customer support, helpdesk, field audit, and other workflow or issue management systems. Use out-of-the-box solutions or implement a custom requirement. Available as a service in the cloud or on your own servers. Simple to configure, yet provides a quality platform on which to implement fully validated systems such as incident management, CAPA, adverse event reporting, & root cause analysis, clinical trial data management and food safety. Implement bug-tracking, customer support, requirements management, change management and other issue-tracking systems. Many customers can take advantage of the full-featured, free, downloadable version! Learn how financial companies implement systems that regulate and control audit systems, provide corporate governance and risk management.Starting Price: $400 one-time payment -
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QFacts
QFacts
QFacts is a cloud-based Quality Management System for pharmacies, compounding facilities, and regulated industries. It covers the full quality lifecycle: controlled document management with version control and approval workflows, training and competency tracking with curriculum-based assignments, event and complaint handling, root cause investigations, CAPA management, and change control. All with complete audit trails. Built for GAMP 5 and European GMP/GDP compliance, QFacts enforces role-based access control across organisations, sites, and departments. Quality managers configure review workflows, track due dates, and monitor compliance through real-time dashboards. Every action is logged and traceable, giving inspectors and auditors a clear chain of accountability from document approval through training completion to corrective action closure.Starting Price: $17/month/user -
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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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QualityPro by TecWork
TecWork Global Business Solutions Pvt. Ltd.
QualityPro by TecWork is a modern, 𝐞𝐧𝐭𝐞𝐫𝐩𝐫𝐢𝐬𝐞-𝐠𝐫𝐚𝐝𝐞 𝐰𝐞𝐛/𝐜𝐥𝐨𝐮𝐝-𝐛𝐚𝐬𝐞𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 (𝐐𝐌𝐒) designed to help manufacturing , automotive, and regulated organizations strengthen compliance, reduce operational risk, and build a proactive quality culture. Unlike traditional systems that only store documentation, 𝐐𝐮𝐚𝐥𝐢𝐭𝐲𝐏𝐫𝐨 𝐐𝐌𝐒 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 connects quality processes into one intelligent platform—ensuring clarity, accountability, and audit readiness across the entire organization. QualityPro centralizes critical QMS workflows including: ▶ Non-Conformance & Deviation Management ▶ Corrective and Preventive Actions (CAPA) ▶ Complaint Handling & Customer Quality Events ▶ Audit Planning & Execution ▶ Calibration & Equipment Management ▶ Inspection & Quality Control ▶ Document Control ▶ Training Management & Competency Tracking ▶ Risk Management & Continuous Improvement ▶ Change ManagementStarting Price: Contact us for pricing -
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Clearlane Breach & Incident Reporting
Clearlane Apps
Clearlane Breach & Incident Reporting is a Jira Cloud app for teams managing GDPR personal data breaches and NIS2 or DORA incidents. It provides a qualification workflow that records the event and the time the organization became aware, then calculates applicable reporting deadlines and tracks status in a register. The app prepares notification text for teams to copy into authority forms, records submission dates and references, and maintains an evidence trail with signed decisions and PDF records; the breach register can be exported as CSV. Jira and Jira Service Management work items are supported. The app does not submit notifications to authorities or make the legal assessment, and national authority forms are not included. It runs on Atlassian Forge within the customer's Atlassian site and supports English, French and German.Starting Price: $69/month -
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Clearlane Delivery
Clearlane Apps
Clearlane Delivery is a Jira Cloud app for planning and tracking project work. It combines a drag-and-drop Gantt chart with milestones, dependencies and working-day settings; reports time spent in each Jira status and highlights work that is taking longer than a team’s usual pace. Monte Carlo forecasts estimate likely and safer-to-promise finish dates for projects, versions or epics, while budget views compare logged time and expenses with planned amounts and forecast final costs. The app also provides Jira dashboard gadgets for flow, throughput, cumulative flow, sprint burndown, velocity, work-in-progress aging and cycle time. Teams can enable or disable app sections, and use the Jira data and permissions already in place without migrating work items. Clearlane Delivery runs on Atlassian Forge for Jira Cloud and follows each user’s English, French or German Jira language.Starting Price: $0 -
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Clearlane CRA
Clearlane Apps
Clearlane CRA is a Jira Cloud app for manufacturers and product security teams managing Cyber Resilience Act vulnerability reporting. It turns Jira vulnerability and incident work items into records for Article 14 deadlines, prepares ENISA reporting fields for review and copying, and tracks affected products and versions using CycloneDX or SPDX software bills of materials. Teams can record fixes, inform users, create CSAF 2.0 security advisories, and keep PDF evidence with Jira work items. The app supports English, French and German and runs on Atlassian Forge. It does not submit reports to ENISA; users assess their obligations and submit through the authority's reporting platform.Starting Price: $69/month -
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qmsWrapper
qmsWrapper
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance. Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.Starting Price: €3,499 -
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PaKalite
PaKalite
PaKalite is a quality management system for small and mid-sized automotive and industrial manufacturers, built on IATF 16949, ISO 9001/14001/45001, AIAG (PPAP, APQP, MSA, SPC) and VDA 6.3. 17 integrated modules: PPAP (18 elements, PSW, MSA/GRR), APQP (5 phases), audits (14 types, question bank, scoring, findings to CAPA), KPI scorecards (targets, deviation alerts, supplier rating), inspection & control plans (12 types, SPC Cp/Cpk, quarantine, EN 10204 certs), calibration, drawing revision control, nonconformity (NCR/8D), continuous improvement (Kaizen, 5S), supplier quality, management review, meetings, HR competence and training, TPM maintenance, OHS, and document management. Modules feed each other: an audit finding opens a corrective action; a chronic KPI deviation triggers one automatically. Cloud data with a Windows desktop client and an Android shop-floor app. PDF reporting, Excel import, role-based permissions, per-company data isolation. Free plan. Turkish interface.Starting Price: $0 -
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Quality Forward
Quality Forward
Quality Forward is a cloud-based electronic Quality Management System (eQMS) designed to help organizations in highly regulated industries digitize, manage, and automate their quality processes within a unified platform. Built on the ServiceNow architecture, it enables teams to centralize and control critical workflows such as deviations, corrective and preventive actions (CAPAs), audits, complaints, change control, document management, training, supplier quality, and risk management, all with full traceability and audit-ready documentation. It provides real-time monitoring, automated workflows, and AI-driven insights that streamline compliance, reduce manual effort, and improve operational efficiency across the product lifecycle. It offers a highly configurable, no-code environment that allows quality assurance teams to adapt processes to evolving regulatory requirements without relying on IT, while maintaining adherence to global standards such as FDA, ISO, and GxP. -
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BizPortals QCFlow
BizPortals QCFlow
BizPortals QCFlow is a comprehensive Quality Management System (QMS) software designed to help organizations manage quality, ensure regulatory compliance, and support continuous improvement. The platform provides an integrated solution for CAPA management, document control, audit management, nonconformance management, risk management, training management, inspection management, and supplier quality management. With a flexible and configurable architecture, QCFlow enables businesses in manufacturing, life sciences, healthcare, and regulated industries to automate quality workflows, improve traceability, and maintain compliance with quality standards such as ISO 9001, ISO 13485, and GMP. The system enhances visibility across quality operations, reduces manual processes, improves collaboration, and helps organizations consistently deliver high-quality, compliant products and services. -
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Tollgate
Softwired Digital
Tollgate gives you the tools to manage the money, scope and schedule of projects and portfolios without leaving Jira. It keeps this separate from your agile delivery workflows and doesn't touch Jira work items. Build a cashflow model and calculate NPV and IRR Create work packages from cost items and baseline cost, time and scope. Link them to Jira work items without changing your product breakdown structure. Manage risks, decisions and change requests without leaving Jira. Build portfolios across projects to see total investment, related risks and more. Every action and decision is captured in exportable audit logs. RAG status and project reporting commentary is maintained and presented from the same surface, removing the need to prepare monthly slide decks. Custom "Ask Tollgate" agent built on Atlassian Rovo provides deep insight across in-scope Jira, Tollgate and Confluence pages, access controlled by governance group and project membership.Starting Price: Free for up to 10 users -
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foodflou
foodflou
foodflou gives food companies full supplier visibility and strong document control across all food safety and compliance work. CAPAs, NCRs, complaints, forms, inspections, audits, risk assessments, supplier questionnaires, and all related documents sit in one accurate and customizable system. This removes scattered PDFs, spreadsheets, and shared drives that cause version problems and audit issues. Teams work with clear ownership and up to date information, and suppliers stay aligned through direct sharing and easy imports. Automated tasks and simple workflows keep requirements on track and reduce common audit risks. With fast onboarding and everything in one place, companies strengthen food safety management and maintain consistent GFSI and BRCGS audit performance.Starting Price: €129/month -
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QISS Quality Management System
Quality Institute of America
Document Control is a document management service whose purpose is to support controlled processes and practices for creating, reviewing, correcting, issuance, and distributing of documents. ISO standard-based QMS QISS Offers CAPA Management Software System for Automating Corrective Action Processes in Regulatory Environments. Adopt your own risk-based thinking. Centralize to prevent and mitigate your risks. Standardized workflow helps you stay in control of changes in your organization. Build a paperless document management system with numerous additional benefits. Develop a culture of continuous improvement with the visibility of each non-conformance. -
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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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IMSXpress is a cutting-edge document control and quality management system (QMS) software solution. Easy to install and intuitive, IMSXpress Quality Management improve the overall business efficiency while maintaining compliance. The solution offers a plethora of modules, such as document distribution, document control, internal audit, training, management review, Corrective/Preventive Action (CAPA), customer companies, risk management, preventative maintenance, measuring equipment, supplier control, and more.Starting Price: $790.00/one-time
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42
Qualifyze
Qualifyze
Upgrade your quality compliance management to our secure, cloud-based solutions. Manage every step of your audits, in one place, including CAPA follow-ups, auditor CVs, real-time audit status updates, audit report repository, and much more. Our platform connects customers, suppliers, and auditors for centralized control across all sites. Access the world’s largest audit database with 2300+ audits, using our shared audits model and existing reports, without the hassle of organizing new audits. Supplier directory simplifies your search for new or backup suppliers, with more than 24,000, and the most diverse range of products and services in the industry. Qualify and select the best partners with instant access to their latest audit reports, warning letters, compliance details, and quality ratings. Experience the fastest and most effective onboarding process in the industry. We offer weekly updates on observation ratings and CAPA performance. -
43
ProcessMAP
ProcessMAP
Streamline processes and manage associated risks with the most integrated suite of Health & Safety software solutions. With ProcessMAP, companies establish consistency and provides realtime insights to improve your Health & Safety performance and ROI. Streamline, standardize, and track processes essential to various regulations and compliance frameworks. Built-in alerts, robust CAPA management, and advanced reporting capabilities increase accountability, provide visibility across the organization, and keep you ready for audits and inspections. Reduce risk through the correlation of safety and claims experience data. Identify and mitigate unsafe activities and associated risk by analyzing the root cause of events and claims. Our platform helps reduce risk by stopping claims before they happen. Manage sustainability performance and metrics reporting with the industry's leading cloud platform. Streamline collection, verification, and analysis of company-wide KPIs. -
44
SalesForge CRM
DevSamurai
SalesForge CRM transforms Jira into a unified sales and relationship management hub. Designed as a 100 % Forge-native app, it runs securely within the Atlassian ecosystem, so sales and project teams work together—without switching platforms. Key Features & Capabilities - Lead & Deal Pipeline Management - Contacts, Accounts & Customer Records - Integrated Email & Templates - Forge-Native & Secure Data Handling - Team Collaboration & Visibility SalesForge CRM enables teams already working in Jira to manage sales pipelines, customer relationships, and communications—all without leaving Jira. By consolidating CRM functions into the Atlassian environment, it removes context switching, prevents data silos, and aligns sales with product and support workflows. The result: faster adoption, greater visibility, and measurable uplift in efficiency and revenue. -
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Clearlane Tests
Clearlane Apps
Clearlane Tests adds test management to Jira Cloud without new work item types. Versioned test cases store steps, test data and expected results, and link to the requirement work items they cover. A coverage view acts as a requirements traceability matrix and identifies requirements with no test case. Plan a campaign for each version or sprint, then run tests step by step. Each run records the exact test case version, pass/fail results and comments for each step, plus the tester and date. A failed step becomes a Jira bug with reproduction steps in one click. Closing a campaign seals it with a fingerprint. Optional electronic signatures record the name, date and time, and meaning; later changes void the signatures. PDF reports include the summary, coverage, results and history. Import test cases from CSV. The app helps teams maintain verification records for IEC 62304, ISO 13485 and 21 CFR Part 11. It runs on Atlassian Forge, so data stays in the customer's Atlassian site.Starting Price: $0 -
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SmartISO
ODACITY LLC
SmartISO is a cloud-based compliance and quality management platform for organizations managing ISO systems internally. It brings document control, internal audits, corrective and preventive actions (CAPA), risk management, training records, management review, supplier evaluation, and quality dashboards into one workspace. Teams can coordinate quality, environmental, and occupational health and safety activities, with workflows aligned to ISO requirements. AI-assisted features support document drafting and analysis, with generated content available for user review. SmartISO is intended for quality and HSE managers, compliance teams, and ISO consultants at small and mid-sized organizations. Plans vary by standards, storage, AI allowances, and other included features; a 14-day free trial is available.Starting Price: $39/month/user -
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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. -
48
Veeva Vault QMS
Veeva Industries
Ensure quality and GxP compliance with Vault QMS. With built-in best practices and automated workflows, Vault QMS brings all parties – pharma and biotech companies, contract manufacturers, and suppliers – into quality processes for better control and visibility. Easily bring departments, sites, suppliers, contract manufacturers, contract test labs, and other partners into continuous quality improvement processes. Increase operational efficiency with automated workflows and built-in best practices. Improve risk visibility across products and processes with a unified approach to risk management. Improve speed, efficiency, and GxP compliance with a unified suite of quality applications. Readily enable quality management processes with built-in best practices for deviation, internal and external audits, complaints, lab investigations, change control, CAPA, and quality risk management. -
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Qualitygram
ORCA LEAN
Qualitygram is a real-time issue capture and problem-solving tool designed for modern manufacturing teams. Using mobile or web, operators can instantly raise quality issues from the shop floor—with photos, videos, part numbers, and comments—and tag cross-functional teams to resolve them faster. It replaces scattered communication (emails, WhatsApp, Excel) with a structured, visual workflow for better traceability and accountability. From new product launches to daily production, Qualitygram helps reduce time-to-resolution, track defect trends, and build a digital knowledge base for recurring problems. 🔑 Key Features & Benefits: Mobile/web issue capture with rich media Real-time dashboards for live tracking Built-in 5-Why & CAPA workflows Cross-functional collaboration with alerts COPQ tracking and root cause analysis Optional AI insights for trend detection -
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Metaware QMS Platform
Metaware
Metaware.nl is a modern, scalable quality management software platform that helps organizations implement, manage and continuously improve their Quality Management System (QMS or GRC). The platform fully supports ISO 9001, ISO 14001, ISO 27001 and other international standards, enabling organizations to demonstrably comply with laws, regulations and certification requirements. Metaware centralizes document control, process management, risk management, incident and complaint management, CAPA, internal audits and management reviews in one secure, cloud-based sovereign solution. With real-time dashboards, workflow automation, role-based access and version control, organizations gain full control over quality, compliance and operational performance. Metaware reduces administrative burden, increases transparency and supports continuous improvement, making it suitable for both SMEs and enterprise-level organizations focused on professional quality assurance and compliance management.Starting Price: €142/month (Bronze)
