Compare the Top FMEA Software as of January 2026

What is FMEA Software?

FMEA software is a computer application used to aid in the Failure Mode and Effects Analysis process. It helps organizations identify potential failure points, prioritize risks, and implement corrective actions for improved product quality. The system typically involves assigning severity levels to each identified risk, followed by documenting countermeasures taken to reduce the likelihood of these issues occurring in the future. FMEA software can be an invaluable tool for preventing costly errors within a manufacturing or engineering organization. Compare and read user reviews of the best FMEA software currently available using the table below. This list is updated regularly.

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    Intelex

    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.
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    Total Lean Management (TLM) Software

    Total Lean Management (TLM) Software

    Lean & Mean Business Systems

    Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work Orders
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    Starting Price: $45/user/month
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    FMEA Database

    FMEA Database

    Sunday Business Systems

    Build a simple and efficient Quality Management System (QMS). Install on your local server or leverage our Cloud QMS solution. Implement risk based thinking required by ISO 9001:2015. Risk Assessment: Failure Modes and Effects Analysis (FMEA). Implement risk based strategies for ISO 9001:2015, ISO 14971. Identify failure modes for each process or item. Identify effects and severity. Identify causes and frequency. Identify current controls and detection levels. Develop multiple actions associated with this failure mode. Assign owners and due dates. Establish verification and validation criteria. Electronic signature for management approval. User login: define user passwords and privileges. Rich set of reports. Track open actions and delinquent due dates. Free runtime version of Access is available from Microsoft. Export data to Excel for further analysis. Common, convenient software platform.
    Starting Price: $135.00/one-time
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    PLATO e1ns
    PLATO e1ns is the central platform for the optimal design of the product development process. Transparent development processes, a common understanding of the system and good, networked collaboration provide the basis for economic, fast and successful product development. PLATO e1ns is the system for the optimal design of the product development process (PDP). With e1ns PLATO has developed a solution that works in the early stages of PDP. Right where you lay the foundation for cost and risk avoidance. e1ns combines methods and development phases in a system. Under its aspects the system model modeling (SysML) each discipline (mechanical, software, electrical, etc.) "Single Point of Information" - central and direct access to all networked data and measures within the product development process via web browser. We will put together a customized methods framework that is designed specifically for your development process.
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    QAD EQMS
    QAD EQMS, formerly CEBOS, is a fully integrated enterprise quality solution that provides timely visibility into manufacturing and quality related issues. It facilitates a preventative approach resulting in reduced cost of quality, improved manufacturing throughput, improved customer satisfaction and higher manufacturing margins. QAD EQMS addresses the breadth of the value chain of suppliers and internal manufacturing to optimize quality performance.
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    Knowllence

    Knowllence

    Knowllence

    Risk management integrator. Knowllence offers software and training and consulting services for truly effective QSE risk management. Manage the Safety of your employees (single document, arduousness, chemical risk). Manage your robust design process (functional analyzes, FMEA FMEA, FTA). Manage the robustness of your industrialization (AMDEC Process FMEA, monitoring plan). Control risks according to ISO 14971 and the design of your medical devices. We understand the methodologies that suit you and adapt, if necessary, the configuration of our software to precisely follow your standards and processes. We are able to provide you with a complete service to facilitate your work sessions and your risk studies, in order to move your project forward, while making the system sustainable: you keep control of the study and the plans of actions within efficient and easy-to-use software.
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    PHA-PRO

    PHA-PRO

    Sphera

    Risks are inherent in asset-intensive, high-hazard facilities, and especially where the risk data set is vast with process safety risk spread across the organization. It’s difficult to standardize and assess all the sources of risk to support resource-intensive facilities. Sphera’s PHA-Pro offers a framework, configurable methodologies and risk assessment workflows to help organizations standardize and record risk assessment data and ensure proper controls are in place. Our PHA-Pro software is the most recognized and respected hazard identification and risk assessment tool for strengthening the risk assessment process. It helps identify, assess and control the impact of process-related risk. And Our expert facilitators have extensive experience performing risk assessments based on any methodology, including: HAZOP, What/If FMEA, FMECA PHA revalidation Workplace Job Safety Analysis (JSA) Layers of Protection Analysis (LOPA) and Safety Integrity Levels (SIL) SVA
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