Best CAPA Software in Japan
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Compare the Top CAPA Software in Japan as of November 2025
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What is CAPA Software in Japan?
CAPA (Corrective and Preventive Action) software helps organizations identify, manage, and resolve issues that affect product quality or compliance by tracking corrective and preventive actions. It streamlines the process of investigating root causes, implementing corrective actions, and preventing future occurrences, ensuring continuous improvement in operations. The software automates tasks like incident reporting, workflow management, and documentation, allowing for more efficient handling of quality and compliance issues. CAPA software also provides detailed reporting and audit trails to support regulatory compliance and enhance accountability. Overall, it helps businesses improve product quality, reduce risks, and maintain compliance with industry standards. Compare and read user reviews of the best CAPA software in Japan currently available using the table below. This list is updated regularly.
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1
HSI Donesafe
Donesafe
Turn obstacles into growth opportunities with HSI Donesafe’s CAPA Software. Simplify corrective and preventive actions using intuitive tools designed for speed, transparency, and collaboration. Ensure issues are addressed promptly, minimizing disruptions and developing a proactive risk management approach. Empower your team to resolve challenges efficiently, focusing on continuous improvement. Discover true configurability with our no-code platform. Simply change what you need when you need with our easy-to-use drag and drop function. By promoting accountability at every level, Donesafe cultivates a culture of learning and resilience. Setbacks become progress when you create a future where safety, operational success, and continuous improvement go hand in hand, driving long-term growth and safety outcomes. -
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SBS Quality Management Software
Sunday Business Systems
The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server. Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - EHS module SBS Ground Control - Employee training management (LMS) - Document control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans Great product for efficient and affordable QMS ComplianceStarting Price: $4,268 one time fee -
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Intelex
Intelex Technologies
Intelex is an integrated software solution for managing Environmental, Health, Safety and Quality (EHSQ) programs. Intelex’s scalable platform is designed to store, manage and analyze EHS and Quality data in one place. The solution works on any device to meet the realities of your workplace. With Intelex, your organization can: - Drive better results in your EHSQ program by monitoring workflows to achieve top performance and gain control. - Identify trends and tendencies by setting goals to gain greater insight into your EHSQ program to enhance judgement. - Reduce incidents and administrative work by easily monitoring, managing, optimizing and drawing insights from your safety data with our user-friendly safety software solution. - Streamline air, water and waste emissions management and reporting, and track and manage environmental outputs to achieve sustainability goals. - Drive continuous quality improvement activities across multiple departments, sites or locations. -
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Certainty Software
Certainty Software
Improve Performance and Sustainability with Certainty! Certainty is an enterprise-level software solution to easily collect and report inspection data and manage issues identified. Used by hundreds of thousands of professionals to complete millions of audits and inspections annually, Certainty helps companies around the globe ensure compliance, reduce risk, and improve performance with easy-to-use forms, real-time reports, and complete action management. Collect, track, and report accurate and powerful data to provide detailed business insights that will empower your team to improve performance and business sustainability. Certainty is used worldwide for: Safety inspections Quality assurance and control audits Supplier and supply chain compliance audits ESG assessments And much more . . .Starting Price: $18 per user per month -
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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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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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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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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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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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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 -
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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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Cognidox
Cognidox Ltd
Cognidox is an online document management system for high-tech, medical device and life sciences product development sectors. Available in the cloud or as an on-premise solution, Cognidox promotes better product lifecycle management and knowledge transfer from developers to clients, partners, and customers. Secure and reliable, Cognidox provides plug-ins for various programs such as Microsoft Office, and we also offer a robust API so that you can integrate almost any process with Cognidox In addition to the core function as a DMS, an add-on for Cognidox also offers a way of allowing licensing and distribution of documents to third parties via fully sandboxed site so you have the power to publish specific documents whilst keeping your main storage secure. Another popular add-on is the gBMS - graphical Business Management System, Use Visio to easily capture your business processes, a good BMS should give you clear oversight of your entire operation.Starting Price: £10 p/user -
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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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MyBlueLabel
MyBlueLabel
Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated in your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.Starting Price: $235 per month -
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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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Falcony
Falcony
Reveal the unreported and uninspected. Get unprecedented involvement and visibility to build safer, happier, and more productive workplaces with your employees. The frontline employees and managers now expect frictionless mobile-first experiences from reporting, workflows, and communication. Most reporting systems fail to involve and are used only by a small fraction of people. This all leads to insufficient or skewed situational awareness with unwelcome surprises. It’s not the management teams, but all your people in the field who are aware of the pressing issues and all the tiny observations that impact your business and operations. What they are waiting for is to have a voice, to be involved, to solve problems, and to have an impact. Having different reporting tools for individual functions increases the threshold of use for end-users. Falcony empowers your employees and stakeholders with a perfect companion to reveal everything they observe, inspect, collaborate and resolve.Starting Price: €150 per month -
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ECAT
Electronic Compliance Audit Tools
ECAT, a cloud-based audit management solution, enables organizations to monitor, review and generate reports on safety inspections. ECAT offers key features such as offline mode, inspection scheduler, and multi-field inspections. ECAT helps organizations conduct inspections for hygiene, production, equipment, security, general safety and more.Starting Price: $40.00/month/user -
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EHS Insight
EHS Insight
EHS Insight is an environmental, health and safety (EHS) management platform that empowers organizations to ensure company-wide compliance. Affordable and quick to setup, EHS Insight offers the best value in EHS software today by providing businesses with the tools they need to manage incidents, audits and inspections, compliance obligations, corrective actions and more. EHS Insight also comes with fantastic support to assist businesses during and after software implementation.Starting Price: $200.00/month -
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IMEC Safety Management Software
IMEC Technologies
IMEC Safety Management Software, formerly Inspector, is a cutting-edge inspection and incident management software solution that is composed of two modules each with a mobile app. The Inspections module enables users to manage, schedule, track, and report on any type of inspection, including safety, equipment, and facilities in single or multiple sites. On the other part, the Incident Management module enables users to manage, report, and track hazards, incidents, and near misses. Checklists can also be used to capture Text Inputs, Numeric Inputs, Date Input, Signature Capture, GPS Location, QR Codes / Barcodes. QR Codes / Barcodes can be used to trigger the inspection to commence, the user simply scans the code of the item to be inspected and the inspection will start. A wide range of QR Codes / Barcodes are supported as standard.Starting Price: $12 per month -
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EcoOnline
EcoOnline
Through a comprehensive platform, EcoOnline offers all the modules that a company needs to create safe, compliant and efficient workplaces. The functionally rich integrated platform ensures real-time decision support and EHS analytics, drive efficiency, whilst safeguarding your workforce, customers, and company reputation. With EcoOnline’s digital solutions, following safety management best practices is easy, effective and even inspiring. Use our mobile app to engage employees and build a lasting safety culture. The most user-friendly chemical safety software on the market that gives control back to employees who manage chemical safety. Take control of your SDS Management, Risk Assessments and Chemical Reporting. EcoOnline's Environmental Reporting Software modules allow you and your organization to track and reduce organizational emissions, optimize raw material usage and automate and schedule regular reports. -
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Xybion QMS
Xybion
Rapidly Transform your Compliance, Quality & Risk Management Systems for Today’s All-Digital, All-Remote World :Predict, Mitigate, Automate and Monitor Compliance in Real-Time. Be Always Compliance Inspection Ready -
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BlueKanGo
BlueKanGo
Digitize your processes. Security. Environment. Quality. Hygiene. Of Business. Centralize. Simplify. Automate. One tool to manage everything. For a sustainable performance of your organization. The performance and safety of an organization is based on automated processes. BlueKanGo is the digital EHSQ solution to manage them. Whether you are looking to address societal and environmental issues, minimize your risks, improve your operational excellence, rely on the solution approved by more than 3500 customers for more than 18 years. Digitize your Quality, EHS and more processes. Quality & audits management. Health and Safety of employees. Environment. CMMS & inspection. Certification, Standards. Corporate Social Responsibility (CSR). Regulatory Watch. Strategic Planning. 6 differences that are our key strength. With more than 18 years of existence, BlueKanGo is the SaaS platform that has no limits but your imagination. An innovative, scalable and all-inclusive solution -
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Cikaba
Cikaba
Risk prevention: don't wait to be overwhelmed by the 2nd wave. Digitize your prevention processes to adapt to the health protocol: rapid and remote distribution of your instructions, monitoring of entries and exits on your sites, adaptation to new government instructions and simplified management of your reception processes. Time saving. Free up your teams' time: automate your prevention processes related to Covid as well as your activity. Quick to install Simplified piloting. Unify your reception and re-reception processes (registrations, follow-up, etc.) Traceability guaranteed. Facilitate the traceability of contact cases and be in compliance with regulatory requirements. Increased security. Targeted messages. Adapt your content according to your audiences (employees, external companies) and your different sites. Raise awareness - Disseminate - Train - Anchor - Prevent. Beyond the legal constraint, in a context marked by strong concern, the success of the continuationStarting Price: $600 per year -
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PICC Software
PICC SOLUTION
Capture, connect and share knowledge from experience feedbacks, documents and IoT devices to enhance your business intelligence and innovation capability. PICC Software is a result-oriented, all-in-one platform for all use cases where know-how is a key factor for business success. PICC Software is the only platform capable of analyzing experience feedbacks and data, and then aggregating them with company’s explicit knowledge. The result is immediately actionable solutions made available for all your staff, anytime, anywhere. Stop reinventing the wheel, uncover new opportunities, reach new levels of excellence with PICC Software. All the problems under review within your organization and all considered solutions aggregated by artificial intelligence in a collaborative knowledge map. The inventiveness of your experts augmented with artificial intelligence and guided through a scientifically demonstrated method to manage efficiently all your innovation projects.Starting Price: €2.5 per day and user -
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ReliaSoft
Hottinger Brüel & Kjær (HBK)
ReliaSoft software provides a powerful range of reliability software solutions to facilitate a comprehensive set of reliability engineering modeling and analysis techniques. We are the leading reliability solution provider for product test, design, maintenance strategy and optimization. Our products support a wide range of reliability and maintainability analysis techniques, such as life data analysis, accelerated life testing, system modelling and RAM analysis, reliability growth, FRACAS, FMEA and RCM analysis to meet and improve reliability of your products, processes and optimize maintenance planning. -
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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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InfinityQS
Advantive
InfinityQS is the leading global provider of Statistical Process Control (SPC) software solutions for manufacturing optimization. Powered by our advanced SPC analytics engine, our cloud-based and on-premise SPC solutions capture and centralize critical production data, enabling manufacturers to get extraordinary value from their data to optimize performance, improve process capability, enhance productivity, and make smarter decisions. Our manufacturing solutions are also highly configurable, with enterprise, multiple-site, and single-site solutions available to fit the needs of simple to complex manufacturing environments. -
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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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CAQ.Net
CAQ AG Factory Systems
CAQ AG Factory Systems has established itself as one of the worldwide leading providers of quality management software. We have over 30 years of experience in the development and distribution of modular, multilingual, and industry-specific management solutions for small and medium-sized enterprises as well as multinational corporations. Our CAQ.Net software suite covers every aspect of computer aided quality assurance and was designed with the highest degrees of adaptability and customizability in mind. Just like a construction kit, our system allows you to pick the most suitable building blocks and thereby create the perfect solution to your individual quality management demands. Why CAQ.Net? Updates, Upgrades & Release Changes Support from QM & IT Professionals User Workshops Screencasts Conformity to Standards Information Security SaaS or On-Premises Floating Licenses Multitenancy Multilingual No-Code-Designer Validation Capability AI Assistants ... -
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ComplianceQuest
ComplianceQuest
Fastest growing Enterprise Quality, Health and Safety Management System (QHSE) natively built and run on the Salesforce platform. Unified QHSE solutions, which combine EQMS and EHS, help our customers of all sizes deliver quality products and services in the safest, most sustainable way by mitigating risk, problems, and inefficiencies while protecting customers, employees, suppliers and brand. Every organization – irrespective of its industry, geography or size – involves an interaction of activities and processes with the environment. These activities may have an adverse or favorable impact on the environment depending on the type of activity being carried out. Our Environment Management solution has been designed to minimize and mitigate these adverse impacts on environment, to such an extent that our already depleting biodiversity is protected, and nurture an ecosystem where all living organisms coexist sustainably.Starting Price: $30 per user per month