List of the Top 25 CAPA Software for Windows in 2025

Transform challenges into opportunities for growth with HSI Donesafe's CAPA Software. Streamline your corrective and preventive actions through user-friendly tools designed for efficiency, clarity, and teamwork. Ensure that problems are resolved swiftly to limit interruptions and foster a proactive approach to risk management. Equip your team to tackle obstacles effectively, while prioritizing ongoing enhancements. Experience unparalleled flexibility with our no-code platform. Instantly modify elements as needed through our intuitive drag-and-drop interface. By fostering responsibility at every level, Donesafe nurtures a culture of development and resilience. Turn setbacks into stepping stones for progress by creating a future where safety, operational excellence, and continuous enhancement are interconnected, propelling sustainable growth and safety achievements.

Certainty is a comprehensive software solution for auditing and inspection that offers reliable support in managing and reporting on business risks, compliance, and performance indicators swiftly and effectively. Utilized by countless professionals, Certainty Software facilitates millions of inspections and audits annually, equipping users with essential tools to gather, organize, and present precise, consistent, and actionable metrics throughout the organization. In addition to its data management capabilities, Certainty empowers users to design, oversee, and report on inspection and audit findings while also assisting in the identification and mitigation of risks, incidents, and challenges that may arise during the auditing process. This software not only enhances operational efficiency but also ensures that businesses maintain high standards of accountability and performance.

TLM QMS Software is an advanced and reliable platform for quality, risk, and material management that meets validation and 21 CFR Part 11 compliance standards. This innovative, comprehensive quality management system is designed for customization, allowing seamless integration with online CRM solutions, QuickBooks, or ERP systems. Total Lean Management (TLM) QMS Software aims to provide an economical and highly cohesive environment that is adaptable and continuously evolving, enabling the incorporation of specialized systems as necessary to develop a digital business ecosystem tailored to your organization’s workflow requirements. This flexibility ensures that the software can grow alongside your business, responding effectively to changing needs over time.

qmsWrapper is a comprehensive Quality Management Software designed specifically for small businesses and startups. This tool is ideal for organizations aiming to boost efficiency by adhering to ISO 9001:2015 standards, as well as for MedDev creators seeking to seamlessly navigate the requirements of ISO 13485:2016 and 21 CFR 820. It is particularly beneficial for businesses that require assistance in establishing and utilizing an effective, validated Quality Management System. Additionally, it serves companies looking to streamline their quality management processes by transitioning from traditional paper-based methods to automated solutions.

Streamline the detection and resolution of issues within your organization and supply chain through automation. This CAPA software application is highly regarded and has gained the trust of thousands of users across the globe. The CAPA Manager software enhances the corrective action process by automating the assignment, notification, investigation, and reporting of corrective actions. By doing so, it reduces the likelihood of errors throughout the entire CAPA process, from initiation to investigation and final closure. Furthermore, CAPA Manager complies with key quality management standards such as ISO 9001, AS9100, and TS 16949. It effectively tracks records related to root-cause analysis and corrective actions, while also offering pre-defined workflows that include approval checkpoints to ensure thorough oversight. This comprehensive approach not only boosts efficiency but also enhances overall quality management within organizations.

The Qualityze EQMS Suite represents an innovative approach to Enterprise Quality Management Software, tailored for organizations aiming to streamline their quality processes, meet customer demands, and adhere to compliance standards. This software empowers businesses to tackle operational hurdles, thereby enhancing their performance in quality, safety, and reliability. With a variety of pre-defined templates available for controlled documents, audit checklists, regulatory forms, and material compliance reports, it offers comprehensive support. The suite consists of 14 interconnected modules that facilitate a complete quality management system accessible from any location. Built on the robust Salesforce.com technology platform, these modules include 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, Maintenance Management, and Field Safety Management. By leveraging our Quality Management solutions, organizations can foster a culture of quality and drive continuous improvements, effectively addressing and mitigating potential quality challenges before they escalate. This proactive approach not only improves overall operational efficiency but also solidifies customer trust and satisfaction.

ACE Essentials serves as an Electronic Quality Management System Software (EQMS) that has been pre-validated for use in industries that are highly regulated. This comprehensive system encompasses ten distinct workflows alongside all necessary Standard Operating Procedures (SOPs) and Policies, guaranteeing that your quality management system is compliant right from the outset. Furthermore, ACE Essentials boasts a complete audit trail that meticulously tracks all actions taken within the system, helping you assess the risks linked to your assets. Key features of ACE Essentials include: - Pre-Configured Workflows - Pre-Configured Event Management (such as Due Dates, Scheduling, and Reminders) - Pre-Configured Permission-Based Security - Pre-Configured Full Documentation comprising over 50 documents - Capability for Multiple Sites - Free Upgrades for the Lifetime of the Product - Pre-Configured Task Lists - No Validation Period Required - Pre-Configured In-System Notifications - Pre-Configured Email Notifications This robust system is designed to streamline quality management practices, ensuring organizations can efficiently meet regulatory demands while focusing on their core operations.

Bringing innovative products to market in heavily regulated sectors often feels like an unending series of compromises. However, MasterControl's GxP software streamlines workflows, ensuring that you don't have to sacrifice quality for cost or innovation in the face of regulation. With a perfect blend of completeness and connectivity, combined with a focus on flexibility and speed, MasterControl Quality Excellence turns quality data and processes into a significant competitive advantage. The journey toward modernizing your manufacturing operations begins with advanced software solutions. MasterControl Manufacturing Excellence simplifies the digital transformation of manufacturing, covering everything from work orders and production records to logbooks and work instructions, making it the most straightforward approach to digitizing your manufacturing processes.

Streamline your quality processes with QT9's comprehensive cloud-based Quality Management System (QMS) Software Suite. Designed for ease of use, QT9 QMS features over 25 modules that offer unlimited scalability to meet your needs. Enhance your ISO and FDA compliance efforts with automated email alerts, task lists, and FDA 21 CFR Part 11 compliant electronic approvals. QT9 QMS empowers organizations in the Life Sciences, Biotechnology, Medical Device Manufacturing, and Pharmaceutical sectors to achieve digital transformation in their operations. Stay informed with real-time status updates and instantly visualize your quality metrics. The software includes essential features such as document control, revision management, corrective actions (CAPAs), and nonconformance tracking, among others. Additionally, it facilitates streamlined product releases with modules for Deviation Management, Engineering Change Orders, Failure Mode and Effects Analysis (FMEA), and Inspection Management. Transition to a paperless environment and automate your labor-intensive tasks effortlessly. QT9 QMS is ready for immediate use, allowing you to get started quickly. Experience it firsthand by signing up for a free product tour or beginning your free trial today at QT9qms.com. Embrace the future of quality management and elevate your organization's efficiency.

The SBS Quality Database is an affordable and straightforward software solution that complies with ISO 9001 standards, enabling small enterprises to effectively oversee their Quality Management System (QMS). This tool facilitates the tracking of corrective and preventive actions (CAPA), internal audits, safety enhancements, supplier corrective actions, and ongoing improvement projects. Additionally, it allows for the compilation and analysis of customer survey feedback, as well as the identification and mitigation of risks through its risk management module, which includes FMEA and SWOT analysis. The program also permits documentation of QMS review meetings and their outcomes, along with the identification of interested parties as part of the organization's context. Users can utilize the dashboard for a snapshot of overall performance, with options available for both cloud-based and local installations. It is particularly suited for small businesses aiming for compliance with standards such as ISO 9001:2015, API Q1, AS9100, or TS16949. Prospective users can access free demo downloads from our website, allowing them to evaluate the software before making a purchase decision. Moreover, the system's intuitive design ensures that even those with minimal technical experience can navigate it efficiently.

Dot Compliance has introduced the first ready-to-use Quality Management Solution integrated with the Salesforce.com platform. This innovative solution encompasses a comprehensive array of pre-configured eQMS and compliance processes, allowing clients to implement it swiftly and affordably. Included in the Dot Compliance offerings are complete project validation services alongside product validation packages. Their solution stands out as the most economical option for quality and compliance management in the industry, empowering users to deploy adaptable and scalable solutions without delay. Key quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, and Supplier Quality can be automated effortlessly. Furthermore, the solution is designed to be fully configurable and supports seamless integration, which makes it easy for customers to tailor the system to meet their unique specifications. By prioritizing user needs, Dot Compliance ensures a smooth transition and effective management of quality across various operations.

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, 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, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

The SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency: SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance. SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features. SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management. SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations. Lastly, SBS Vendor Management maintains an approved vendor list, formulates vendor qualification plans, and tracks the qualification history of suppliers. Each of these modules can be acquired individually or in various combinations to meet diverse business needs.

EHS management software is crafted to streamline intricate business challenges. Our deployments are quicker, more economical, and yield higher success rates compared to conventional enterprise software systems. The true advantage of our solution lies not in the software itself, but in its capacity to assist you in accomplishing your tasks and meeting objectives across various departments, locations, and even continents. Our cloud-based solutions are user-friendly enough for frontline staff while being advanced enough to enable you to execute global, top-tier programs straight away. VelocityEHS has established itself as a reliable provider for managing risks, addressing industrial hygiene and environmental issues, as well as handling hazards and incidents. We uniquely offer MSDSonline for chemical management, along with Humantech's solutions for industrial and office ergonomics. With a customer base exceeding 18,000 worldwide, we have earned the trust of organizations seeking effective resolutions to their complex compliance challenges. Our commitment to innovation and excellence ensures that we continually adapt to meet the evolving needs of our clients.

Since 1994, Predator Software has been at the forefront of automating manufacturing processes globally. Their pioneering software applications have garnered multiple awards, showcasing their innovative approach. As a prominent player in Industry 4.0, lean manufacturing, and industrial networking, Predator Software offers a comprehensive suite of solutions. Their SFC technology encompasses a range of capabilities, including CNC networking, overall equipment effectiveness (OEE) monitoring, data collection, machine simulation and verification, tool management, and gage crib management. Additionally, they provide traveler management, CNC post-processing, flexible manufacturing systems, and robotic cell control software, demonstrating their commitment to enhancing operational efficiency and productivity in manufacturing environments. With a focus on continuous improvement, Predator Software is poised to drive the future of manufacturing technology.

MediaLab's Intelligent Quality Engine (IQE) solution is engineered to provide efficient automation for managing non-conforming events in laboratories. By eliminating reliance on traditional paper-based manual investigations and corrective and preventive action (CAPA) procedures, IQE not only reduces costs but also enhances your quality improvement initiatives. This innovative system ensures compliance with corrective and preventive action standards recognized by organizations such as CAP, the Joint Commission, ISO, and various other accreditation entities. As a result, you will experience a more efficient and streamlined process that aids in meeting regulatory requirements. Begin by utilizing our pre-designed online form templates or take the opportunity to customize your own. Empower your employees to report issues as soon as they arise, and MediaLab will efficiently guide your event through every stage of the management lifecycle, including initial reporting, risk assessment, resolution, and evaluations of change effectiveness. Additionally, your existing processes and forms will integrate seamlessly with IQE, enhancing your laboratory's operational efficiency and compliance efforts. Ultimately, adopting IQE leads to a more proactive approach to quality management.

EHS Insight is a comprehensive environmental, health, and safety management platform that enables organizations to maintain compliance throughout their operations. Not only is EHS Insight cost-effective, but it also boasts a straightforward setup process. The platform equips companies with essential tools for handling incidents, conducting audits, managing inspections, meeting compliance requirements, and implementing corrective measures. Furthermore, EHS Insight delivers outstanding support to businesses both during the initial software rollout and in the subsequent stages of utilization, ensuring that users can fully leverage its features for ongoing success. This commitment to customer service sets EHS Insight apart in the market.

Keep a close watch on hazardous waste containers by monitoring their combinations, separations, current positions, origins, and timestamps for disposal. This framework is particularly useful in contexts like Medical Waste Management Software and Hazardous Waste Management Software, which are specifically designed for Waste Generators and Environmental Service Companies. Environmental Service Companies can provide their clients with the ability to view the waste collected from their locations, which streamlines the creation of Total Waste Management (TWM) reports for customers. Moreover, the system supports the tracking of hazardous waste shipments and the individual containers included in those shipments, while also offering detailed reporting on the final disposal status of containers collected from diverse departments and clients. Conduct inspections of RCRA waste areas by assessing each container and documenting any deficiencies found during the process. Users can also retrieve a comprehensive history of all inspections performed through the web portal, which promotes enhanced oversight and accountability. In addition, the system significantly improves compliance by enabling real-time updates and thorough monitoring of hazardous waste management activities, ensuring that all processes align with regulatory standards. This added functionality not only aids in maintaining safety but also fosters a proactive approach to waste management.

Quickly revolutionize your compliance, quality, and risk management frameworks in an entirely digital and remote environment. Anticipate, reduce, and automate real-time compliance oversight, ensuring you are consistently ready for any compliance audits that may arise. In this fast-paced landscape, staying proactive is essential for success.

ReliaSoft offers an extensive array of software solutions designed for reliability engineering, enabling a wide spectrum of modeling and analytical techniques. As a premier provider in the field, we specialize in delivering reliability solutions that enhance product testing, design, maintenance approaches, and optimization efforts. Our software encompasses numerous reliability and maintainability methodologies, such as life data analysis, accelerated lifetime testing, system modeling, and RAM analysis, among others. In addition, we facilitate reliability growth, FRACAS, FMEA, and RCM analyses, equipping you with the tools necessary to enhance both product reliability and process efficiency while streamlining maintenance planning. Ultimately, our solutions empower organizations to achieve superior performance and dependability in their offerings.

CAQ.Net software solutions are utilized worldwide in scenarios where ensuring the quality, safety, and effectiveness of products and services is crucial. From strategic quality management to operational quality assurance, CAQ.Net enhances process management and encourages a company-wide commitment to quality through its advanced automation and consistent data framework, ultimately aiding in the proactive prevention of failures. This comprehensive approach not only streamlines operations but also fosters a culture of quality throughout the organization.

Software designed for regulatory compliance is essential for organizations like Fannie Mae, Wendy's, and Walmart, who rely on a top-tier mobile inspection and audit platform. By utilizing such tools, you can significantly enhance both safety and accuracy within your operations. FORM OpX stands out as the leading field management platform, revolutionizing the way teams interact with Excel, paper, and digital processes. It integrates sophisticated data collection alongside customizable workflows, offering vital operational insights that boost real-time compliance. To promote adherence to regulations, you have the option to implement audits, inspections, or tailored workflows. With digital forms, data can be captured effectively while steering teams toward appropriate actions. Automated alerts can be configured to escalate issues, ensuring timely corrective measures are taken when necessary. Through the creation of personalized workflows, you can streamline processes, enhance compliance, and minimize errors, ultimately saving both time and resources. This approach not only fosters a culture of accountability but also empowers teams to operate with greater efficiency.

Introducing FavoWeb, the premier web-based platform designed for FRACAS (Failure Reporting, Analysis, and Corrective Action). This comprehensive application offers unlimited user access through either a dedicated server installation or a cloud-based SaaS format. Its adaptable configuration ensures it aligns perfectly with your specific workflow, accommodating customized data collection methods, operational protocols, and compliance with business regulations, in addition to providing tailored reports and statistical analyses. By using FavoWeb, you can significantly enhance your failure analysis and corrective action methodologies, as it is recognized as a leading software solution in the FRACAS domain due to its advanced features. FavoWeb not only optimizes your processes but also boosts overall efficiency in handling failures, making it an invaluable asset for any organization. Embrace the future of failure management with FavoWeb to ensure your operations run smoothly and effectively.

Everest, developed by Lynk Software, Inc., is an innovative, cloud-driven complaint management and quality control solution designed to cater to the needs of both large and mid-sized companies across diverse industries. This platform is not only user-friendly but also offers extensive customization options. By efficiently addressing every concern or issue, Everest enhances service quality and fosters customer loyalty. Users of Everest can manage customer inquiries and complaints through multiple channels such as phone, email, mobile applications, remote call centers, and the organization's website, ensuring seamless communication. Additionally, the software's versatility allows organizations to adapt it to their specific operational requirements, making it a valuable asset for managing customer relationships.

Tervene assists organizations in optimizing their operational processes every day. Our integrated worker platform enables both senior leadership and frontline staff to reach high levels of operational efficiency through enhanced daily oversight, teamwork, and effective problem resolution. We have successfully supported leaders in manufacturing and operations, including well-known companies such as Safran, Mars Wrigley, Lactalis, Siemens, and Cascades, in transitioning to digital management practices, encompassing Gemba walks, daily evaluations, audits, inspections, operational meetings, and digital protocols. Our suite of tools includes a Knowledge Center for retaining and sharing expertise, a System Audit feature for performing inspections, Floor Tours and Gemba walks for overseeing operations, a Task Manager to ensure task completion, a Meeting tool to facilitate more productive meetings, an Improvement module for managing enhancements, and a Dashboard for tracking management performance effectively. By leveraging these tools, organizations can foster a culture of continuous improvement and accountability.