List of the Top 6 On-Prem FMEA Software in 2025

BQRG's software suite offers patented tools for automated electronic design analysis and optimization to enhance your design processes: SynthelyzerTM ECAD Plugin supercharges PCB design by providing real-time stress analysis, derating, and thermal simulations, all while seamlessly integrating with ECAD systems to ensure optimal component choices and avert costly mistakes. fiXtress® stands out as a powerful asset in reliability engineering; featuring cutting-edge FMECA, stress, and failure predictions, it helps to prolong product life and reduce downtime significantly. When paired with Synthelyzer™, this combination leads to unmatched design optimization. CircuitHawk™ helps speed up time-to-market by identifying design issues at an early stage, and its sophisticated verification and stress analysis capabilities lay a solid groundwork for creating dependable products. apmOptimizer® is designed to enhance asset value and operational efficiency; through LCC analysis and predictive maintenance strategies, it helps lower costs, optimize spare parts inventory, and guarantees seamless operations. Finally, CARE® prioritizes product safety and ensures adherence to regulatory standards, providing a complete solution for compliance and quality assurance in your designs. This suite collectively transforms the electronic design landscape, making it more efficient and reliable.

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.

Visure Solutions, Inc. stands out as a premier provider of requirements management tool suites, delivering an all-encompassing collaborative Application Lifecycle Management (ALM) platform tailored for the systems engineering sector. Their robust value proposition encompasses cutting-edge technology across essential functions, ensuring adherence to standards for both safety-critical and business-critical systems. Key features of their offering include thorough traceability and requirements management, effective test management, comprehensive issue and bug tracking, and diligent risk management. Additionally, Visure emphasizes collaboration through a centralized database that streamlines the review and approval process, while also providing extensive certification management support for various standard templates such as ISO26262, IEC62304, and IEC61508, along with DO178/C FMEA, SPICE, and CMMI. The platform also excels in configuration management, offering baselining, history tracking, and requirements versioning capabilities. Users can benefit from customizable dashboards and reports tailored to their specific needs. Furthermore, it boasts integration with a wide array of industry tools, including DOORS, Jama, Siemens Polarion, PTC, Perforce, JIRA, Enterprise Architect, HP ALM, Microfocus ALM, and TFS, as well as compatibility with Word and Excel, ensuring a seamless workflow across various platforms. Ultimately, Visure Solutions, Inc. is committed to enhancing the efficiency and effectiveness of systems engineering through its innovative ALM solutions.

Develop a straightforward and effective Quality Management System (QMS) which can be hosted on your local server or accessed via our Cloud QMS option. Adhering to ISO 9001:2015 mandates the incorporation of risk-based thinking. Conducting a Risk Assessment through Failure Modes and Effects Analysis (FMEA) is essential for implementing risk-based strategies aligned with ISO 9001 and ISO 14971. It is crucial to identify potential failure modes for every item or process, assess their effects and severity, determine the underlying causes and their frequency, and recognize existing controls along with their detection capabilities. A series of actions must be initiated in response to each identified failure mode, with clear assignment of ownership and due dates. Additionally, it is important to set up criteria for verification and validation, which can be approved by management through electronic signatures. User login protocols should include defined passwords and privilege levels, while a comprehensive suite of reports will facilitate tracking of unresolved actions and overdue tasks. Microsoft Access can be downloaded free of charge, and for deeper data analysis, the information can be exported to Excel. This system operates on a commonly used software platform that is both accessible and user-friendly, ensuring that organizations can maintain high standards of quality management effortlessly.

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.