Best CAPA Software in South America
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Compare the Top CAPA Software in South America as of April 2026
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What is CAPA Software in South America?
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 South America currently available using the table below. This list is updated regularly.
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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.Starting Price: $1000 per month -
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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.Starting Price: $49/user/month -
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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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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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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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CAPA Manager
Adaptive Business Management Systems
Automate the identification, containment, investigation, and resolution of problems within your organization and supply chain. Trusted by thousands of users globally, this is one of the best CAPA software applications available. CAPA Manager corrective action software automates the assignment, notification, investigation, reporting, and approval of corrective actions. It error-proofs the control of the entire CAPA process, from initiation to investigation and all the way through to closure. CAPA Manager meets the requirements of all important quality management standards: 21 CFR part 11, ISO 9001, AS9100, TS 16949, and more. It keeps records of root-cause and corrective action while providing pre-defined workflows and approval gates.Starting Price: $12.49 per user/month -
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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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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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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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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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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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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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VelocityEHS
VelocityEHS
We deliver EHS management software that solves complex business challenges in simple ways. Our implementations are quicker, cost less and are more successful than traditional enterprise software systems. The real value of our solution is not the software itself, but how well it helps you do your job and achieve your goals — across departments, facilities, locations, and continents. Our true cloud solutions are simple enough for your frontline people to use on the fly, and sophisticated enough for you to run global, best-in-class programs — right out of the box. VelocityEHS brings together the industry’s most trusted solutions for managing risk, industrial hygiene, environmental concerns, hazards and incidents, training and much more. And we are the only source for MSDSonline chemical management and Humantech industrial and office ergonomics solutions. See why more than 18,000 customers worldwide trust us to simplify their complex compliance challenges. -
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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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Predator Software
Predator Software
Since 1994, Predator Software focuses on automating manufacturers worldwide with innovative and award-winning software applications. Predator Software is an industry leader in Industry 4.0, lean manufacturing, industrial networking solutions and automation via shop floor control or SFC. Predator's SFC technologies include CNC networking, machine monitoring, OEE, production data management, data collection, machine simulation & verification, tool & gage crib management, traveler management, CNC post processing, flexible manufacturing systems and robotic cell control software.Starting Price: $250 -
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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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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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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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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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CorrectTrack
CorrectTrack
Corrective Action Workflow. Create Actions. Team leaders and internal auditors can create and assign corrective action tasks from any device. Team members are notified immediately of the new task. Teams stay informed with automated notifications of changes in task stage and approval status. Dashboards, query filters and costume searches helps teams keep leadership informed. Permission based approval-gates help teams ensure tasks are investigated, corrected and the corrective action is verified before the task is closed. What does CorrectTrack do? CorrectTrack is a workflow that gives control over the entire corrective action process. With CorrectTrack you can: Assign corrective actions to team members. Create permission-based workflows to control the process. Communicate task status to team members and leadership. Create dashboards to quickly view performance. Retain evidence and produce reports of who did what and when to investigate.Starting Price: $5.29 per user per month -
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STRATWs ONE
Siteware
Control your indicators and get results quickly. With our strategic management software you will have more time to plan, better organize your routine, manage and engage your team in the culture of results! We go far beyond organizing your routine! Discover the power of strategic management software, capable of improving your business results and engaging your team to achieve your goals. Performance indicator software helps to: Reduce time to collect, validate and consolidate KPIs. Identify problems and create action plans to solve them. Report your results at all levels of the company. Engage your entire team in results-oriented culture. Reach your goals and Improve your business results. Enable everyone to have the necessary conditions to achieve the objectives and goals. Organize the delivery of Strategic Projects and engage people in this process. Improve your team's productivity and make decisions with greater certainty and speed! -
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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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Cority
Cority
Proven solutions to operationalize your pandemic response plans, systematically monitor, and report on the health status of your employees and visitors, and assist your business’ return to productivity. Improve your safety culture by engaging employees, enhancing workflows, and increasing data visibility across all levels of your organization. Cority helps you break down departmental silos, improve reporting, and achieve operational excellence. Cority's unified compliance management solution is designed to help you take the guesswork out of compliance. myCority connects your frontline employees no matter where they are with the tools they need to mitigate risk and drive compliance. EHSQ experts design, implement and support the Cority solution. That’s why we are the leader in Occupational Health, Industrial Hygiene, and Employee Health solutions. Take your safety programs to the next level by proactively mitigating risks, managing compliance, and reducing incidents. -
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ZEBSOFT
Zebra Software
ZEBSOFT GRC & ISO management software platform is a holistic approach to managing Governance, Risk & Compliance. With an intuitive and easy to use web interface, ZEBSOFT makes to easy to manage ISO (9001, 14001, 22301, 27001, 45001) and many other standards. ZEBSOFT has powerful integrated modules for Risk, Quality, Environmental, InfoSec, Compliances, policies (templates included) & documents, equipment & asset management with maintenance/calibration/testing planning. Improve internal communication, assign ownership, plan and carry out audits. Book a demo today to see what ZEBSOFT can do!
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