Best CAPA Software for Windows of 2025

HSI Donesafe CAPA Software turns obstacles into growth opportunities by simplifying corrective and preventive actions with intuitive tools built for speed, transparency, and collaboration. Ensure issues are resolved quickly, minimizing disruptions while fostering a proactive risk management approach. Empower your team to address challenges efficiently, focusing on continuous improvement. HSI Donesafe’s no-code platform offers full configurability with an easy-to-use drag-and-drop interface, allowing you to adapt the system as needed. By promoting accountability at all levels, HSI Donesafe cultivates a culture of learning and resilience. Setbacks become progress, driving long-term growth and improved safety outcomes where operational success and continuous improvement go hand in hand.

ReliaSoft provides a powerful set of reliability software solutions that facilitate a comprehensive range of reliability engineering modeling techniques and analysis techniques. We are the leading provider of reliability solutions for product testing, design, maintenance strategies and optimization. Our products support a variety of reliability and maintainability techniques, including life data analysis, accelerated lifetime testing, system modeling and RAM analysis. We also support reliability growth, FRACAS analysis, FMEA analysis and RCM analysis. These tools help you improve the reliability of your products and processes, and optimize maintenance planning.

Certainty is an enterprise-level auditing and inspection software that can be trusted to help you manage and report on business risk, compliance, and performance metrics quickly and efficiently. Certainty Software is used by hundreds of thousands of professionals to complete millions of inspections and audits each year. It provides all the tools you need to collect, collate, and report consistent, accurate, and meaningful metrics across your business. Certainty provides all the tools you need to design, manage, and report on audit/inspection data, as well as help you manage and mitigate any risks, incidents, and issues that may be identified during the audit/inspection process.

Automate the identification and resolution of problems in your organization and supply chain. This is one of the most trusted CAPA software applications. It has been trusted by thousands of users worldwide. CAPA Manager corrective actions software automates the assignment of corrective actions, notification, investigation and reporting. It prevents errors in the control of the entire CAPA process from initiation through investigation and closure. CAPA Manager meets all requirements of the most important quality management standards, including ISO 9001, AS9100 and TS 16949. It maintains records of root-cause and corrective actions, and provides pre-defined workflows with approval gates.

TLM QMS Software is a powerful and robust quality, risk and material management software (QMS) which is validated and 21 CFR Part 11 compliant. TLM is a cutting-edge, all-in-one quality management system that can be customized to integrate with online CRM software, QuickBooks or ERP databases. Total Lean Management (TLM) QMS Software is specifically intended to be a low cost, highly integrated, flexible and continuously improving landscape to which specialty systems can be added where needed to create the digital business landscape that enables work flows the way your company needs them to work.

Qualityze EQMS Suite is a next-generation Enterprise Quality Management Software. It is specifically designed for businesses to efficiently manage their quality processes, customer expectations and compliance requirements. It helps them address operational challenges so they can achieve excellence in terms of quality, safety and reliability. It comes with pre-defined templates for controlled documents, audit checklists, regulatory forms, material compliance reports and many more. Qualityze EQMS Suite is a set of 14 integrated modules that help create a closed-loop system to manage end-to-end quality from anywhere. Our range of smarter quality solutions is built on the Salesforce.com technology platform. These modules are Nonconformance Management, CAPA Management, Document Management, Change Management, Audit Management, Training Management, Supplier Quality Management, Inspection Management, Customer Complaints Management, Material Compliance Management, Forms Management, Permit Management, Calibration Management, and Maintenance Management, Forms Management and Field Safety Management. Our Quality Management solutions help create a culture of quality and continuous improvements by proactively mitigating quality issues.

ACE Essentials is the pre-validated Electronic Quality Management System Software (EQMS) designed for highly regulated industries. ACE Essentials includes 10 workflows, as well as all the required Standard Operating Procedures (SOPs) and Policies. This ensures that your quality management system is fully compliant from the start. ACE Essentials features include a complete audit trail that tracks every action within the system. This allows you to understand the risks associated assets. Features of ACE Essentials Pre-Configured Workflows Pre-Configured Event Management (Due dates, Scheduling, Reminders) - Pre-Configured Permission Based Security - Pre-Configured Full Documentation - 50+ documents - Multiple Site Capability - No Charge Upgrades for the Product's Life Pre-Configured Tasks Liste - No Validation Period Pre-Configured In System Notifications Pre-Configured Email Notifications

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. Best For 1. For companies who need guidance to implement and adopt validated QMS. 2. For companies who want to automate their quality management and go beyond a paper-based system.

It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation. Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge. Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.

Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com

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.

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance solution includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured processes, enabling customers to deploy quickly and cost effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages. Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to quickly deploy flexible and scalable solutions. Automate core quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, Supplier Quality, and more. Our solution is fully configurable and offers seamless integration abilities, with easy adaptation and implementation of customer’s specific requirements.

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS 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, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

The SBS QMS Suite consists of 5 software modules that work together for efficient Quality compliance: SBS Quality Database - CAPA / 8D corrective and preventive actions (CAR) with root cause analysis - Nonconformance management - Risk analysis including FMEA, SWOT, interested party risk register - Internal, customer, and third-party audit management - Environmental Health and Safety (EHS / HSE) management SBS Ground Control - Employee training management (LMS) - Self-Paced training - Document control SBS Asset Tracking Database - Calibrated equipment control - Preventive maintenance - Asset inventory management SBS Inspection Database - Record incoming material, in process, and final product inspection data - Generate real time SPC charts - Inspection plans and Control Plans - Archive data for further statistical analysis SBS Vendor Management - Maintain an approved vendor list or AVL - Develop vendor / supplier qualification plans - Maintain vendor / supplier qualification history Modules may be purchased separately or in any combination.

EHS management software is designed to simplify complex business problems. Our implementations are faster, more cost-effective, and more successful than traditional enterprise software systems. Our solution's real value is not its software, but its ability to help you do your job and achieve goals across departments, locations, and continents. Our cloud solutions are easy enough to use by your frontline personnel, but sophisticated enough to allow you to run global, best in class programs right out of the box. VelocityEHS is a trusted source for solutions to manage risk, industrial hygiene and environmental concerns, as well as hazards and incidents. We are the only source of MSDSonline chemical management, Humantech industrial and office ergonomics solutions. We have over 18,000 satisfied customers around the world who trust us to solve their complex compliance problems.

Predator Software has been automating manufacturers around the world since 1994. They have developed and won numerous awards for their innovative software applications. Predator Software is a leader in Industry 4.0, lean manufacturing and industrial networking solutions. Predator's SFC technology includes CNC networking, OEE and machine monitoring, data collection, machine simulator & verification, tool management, gage crib management. Traveler management, CNC post processing. Flexible manufacturing systems. Robotic cell control software.

MediaLab's Intelligent Quality Engine (IQE) solution is designed to deliver powerful automation for laboratory non-conforming event management processes. IQE eliminates the need for paper-based, manual investigation and CAPA processes while reducing cost and supporting the quality improvement program. IQE helps your laboratory follow corrective and preventive action standards as outlined by CAP, joint commission, ISO, and other accrediting bodies. You'll benefit from a streamlined approach that supports your regulatory compliance. Start by using our online form templates, or create your own. Allow employees to create events as problems arise. MediaLab will route your event through each phase of the event management lifecycle, from initial event description to risk analysis, closure, and change effectiveness evaluations. Your current processes and forms work beautifully in IQE.

EHS Insight, an EHS management platform, empowers organizations to ensure compliance across the company. EHS Insight is affordable and easy to set up. It provides businesses with all the tools they need for managing incidents, audits, inspections, compliance obligations and corrective actions. EHS Insight offers exceptional support for businesses both during and after the software implementation.

Track hazardous waste containers, track container combinations, and container splits. Know where all containers are located, the origin of each container and the date/time of disposal. These use cases include Medical Waste Management Software and Hazardous Waste Management Software to Waste Generators and Environmental Service Companies. Environmental Service Companies allow customers to view their waste collection and shipping from their site. They can also easily generate Total Waste Management (TWM), customer reports. Track hazardous waste shipments and track containers within a shipment. Report on the final disposition of containers from multiple departments, facilities, and customers easily Perform RCRA waste area inspections, inspect every container, and report and track any deficiencies. You can view a complete history of all inspections that were completed through the web portal.

Rapidly Transform Your Compliance, Quality & Risk Management Systems in Today's All Digital, All-Remote World. Predict, Mitigate and Automate Compliance Monitoring in Real-Time. Always be prepared for compliance inspection

CAQ.Net software solutions are in action all around the globe wherever it is important to ensure the quality, safety, and functionality of products and services. Whether strategic quality management or operational quality assurance – thanks to its high degree of automation and uniform data structure, CAQ.Net facilitates effective process management, proactive failure prevention, and a company-wide quality mindset.

Software that helps you comply with regulations. Fannie Mae, Wendy's and Walmart trust the best mobile inspection and audit platform. This will help you improve safety and accuracy. The #1 field management platform for teams, FORM OpX will transform your Excel, paper, and digital processes. FORM OpX combines advanced data gathering and configurable workflows with powerful operational insight to increase compliance in real time. To ensure compliance and team compliance, you can set up audits, inspections, or workflows. Digital forms allow you to capture data and guide teams to the right actions. Set up automated alerts and escalates to prompt corrective action when issues arise. You can save time and money by creating customizable workflows that improve processes, increase compliance, and reduce errors.

Everest by Lynk Software, Inc., is a cloud-based complaint management and quality control software solution that supports large and mid-sized organizations in a variety industries. Everest is highly customizable and simple to use. It helps organizations improve service quality and customer loyalty by ensuring that every issue or concern is handled efficiently and promptly. Everest users can receive customer queries and complaints via various channels, including phone, email and mobile apps, remote call centers, and the company website.

Tervene helps organizations control their daily operations. Our connected worker platform empowers top management and frontline teams to achieve operational excellence through stronger daily management, collaboration, and problem-solving. Our help helped manufacturing and operations leaders like Safran, Mars Wrigley and Lactalis, Siemens and Cascades to digitize their management practices: Gemba walks and daily checks, audits and inspections, operational meetings and digital procedures. Tools: - Knowledge Center (retain and share knowledge); - System Audit (conduct inspections); - Floor Toor/Gemba walks (control operations); - Task Manager (get tasks done) ; - Meeting (run better meetings) ; - Improvement (manage improvement); Dashboard (monitor management performance).

KPA is a leader in EHS Risk Management, Workforce Management and F&I solutions. KPA's innovative software platform, combined with recurring audit/loss control services, provides the visibility and actionable insights necessary for companies to prevent compliance-related, regulatory, and operational risks. KPA can help you achieve regulatory compliance, manage risk, protect assets, train, retain, and manage employees.