List of the Top 8 On-Prem CAPA Software in 2025

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.

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.

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.

Cognidox serves as a comprehensive online document management system tailored for product development in the high-tech, life sciences, and medical device sectors. Available both in the cloud and as an on-premise solution, it fosters effective product lifecycle management and enhances knowledge sharing among developers, clients, partners, and customers alike. This platform is designed to be secure and dependable, offering plug-ins for a variety of programs, including Microsoft Office, and an API that facilitates the integration of numerous processes with Cognidox. At its core, Cognidox functions as a document management system, and it features an add-on that enables the licensing and distribution of documents to third parties through a fully sandboxed website, ensuring that specific documents can be published while maintaining the security of the main storage. Additionally, one of its notable add-ons is the gBMS, or Graphical Business Management System, which utilizes Visio to map out business processes effectively. A robust business management system not only enhances clarity across operations but also contributes to streamlined workflows and improved visibility throughout the organization.

InfinityQS is recognized as the leading global provider of Statistical Process Control (SPC) software aimed at improving manufacturing efficiency. Our cutting-edge SPC analytics engine powers both cloud-based and on-premise solutions that collect and centralize vital production data, enabling manufacturers to extract remarkable insights from their information to enhance performance, improve process capabilities, boost productivity, and support data-driven decision-making. Moreover, our manufacturing solutions are highly configurable, offering options for enterprise, multi-site, and single-site implementations to handle everything from simple to complex manufacturing operations. This flexibility guarantees that we effectively cater to the varied requirements of different manufacturing environments, ensuring optimal results for our clients. By continually evolving our offerings, we remain committed to helping manufacturers achieve excellence in their operations.

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.

The Audit Manager software streamlines the quality management process by enabling digital monitoring of audits, quality controls, and assessments through every phase, from planning and checklist development to evidence gathering, field assessments, and handling nonconformities. Users can conveniently utilize the integrated calendar feature to schedule audits while including vital information like the subject matter, checklist, lead auditor, co-auditor, and participant details. The system allows both internal and external team members to receive prompt email notifications and access the audit timetable directly within the application. Once the inspection concludes, users can swiftly create audit reports in either PDF or Excel formats, making it easy to share them with company leadership or relevant stakeholders via mobile devices. Additionally, all meeting minutes are systematically archived for easy retrieval, ensuring they can be effectively incorporated into the organization’s document management systems. This efficient approach not only saves valuable time but also fosters improved communication and collaboration among all involved parties, ultimately leading to a more accountable audit process. Moreover, the software's user-friendly interface enhances the overall experience, making it accessible for all users regardless of their technical expertise.