Best FMEA Software
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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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1
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
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 OrdersStarting Price: $45/user/month -
3
Visure Requirements
Visure Solutions, Inc.
Visure Solutions, Inc. is a leading provider of requirements management tool suites offering a comprehensive collaborative ALM Platform for system engineering industries. Visure’s value proposition is nothing less than the total innovative technology in key functions: standard compliance for safety-critical and business-critical systems. - Requirements and Traceability Management - Test Management - Bug & Issue Tracking - Risk Management - Collaboration Management - Centralized data base, Review/Approval process - Certification Management (Support of many Standard Templates ISO26262, IEC62304, IEC61508, CENELEC50128, DO178/C, FMEA, GAMP5, SPICE, CMMI, etc. + Tool Qualification Package) - Configuration Management, Baselining, History Tracking, Requirements Versioning - Dashboards + Report Customization - Integrated with DOORS, Jama, Siemens Polarion, PTC, Perforce, JIRA, Enterprise Architect, HP ALM, Microfocus ALM, PTC, TFS, Word, Excel, Test RT, RTRT, VectorCAST, LDRA, etc. -
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SBS Quality Database
Sunday Business Systems
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.Starting Price: $499/one-time -
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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 -
6
DataLyzer FMEA
DataLyzer International
For manufacturers worldwide, FMEA has become critical in avoiding risk and minimizing quality cost. DataLyzer FMEA links DFMEA, Process Flow, PFMEA, Control Plan. From Control Plan the SPC setup can be automatically created. Many features are available like reference or Foundation FMEAs, different criteria or classification sets, full authorization, Document and issuing control, Action management, Ballooning import, Automatic translation, Reporting, ITAR configuration etc etc DataLyzer® FMEA is one of the modules in the DataLyzer software suite. The program closely follows the methodology defined in VDA AIAG and RM13004. DataLyzer FMEA can operate as a stand-alone module or link to DataLyzer SPC software.Starting Price: $1495 -
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Relyence FMEA
Relyence Corporation
Relyence® FMEA supports DFMEAs, PFMEAs, Boundary Diagrams, P-Diagrams, Process Flow Diagrams, Control Plans, DVP&R, piece-part FMECAs & FMEA-MSRs. Built-in templates supporting the most common FMEA standards including AIAG & VDA Customise your FMEA worksheets, reports, and dashboards to meet your needs Always-in-Sync™ technology keep your PFMEAs, Control Plans and Process Flow Diagrams in sync Knowledge BankTM™ reuse your data, see where its in use and push out controlled updates Data Autoflow™ & SmartSuggest™ for automated controlled data managementStarting Price: £140 per month/per user -
8
QT9 QMS
QT9 Software
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business. Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%. With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management. Start your free trial or book a personalized demo today.Starting Price: $10,000/year -
9
Sunday Business Systems
Sunday Business Systems
Sunday Business Systems (SBS) offers comprehensive quality management software (QMS) and consulting services to improve compliance with quality management standards, including ISO 9001, AS9100, ISO 14001, ISO 45001, and ISO 13485. Our solutions, such as Corrective Action and Preventive Action (CAPA) management, document control, and employee training management, help businesses streamline operations while ensuring compliance with industry regulations. SBS provides software tools for a full rangce of systems including audit management, calibration control, Preventive maintenance, EHS tracking, vendor management and inspection data collection and statistical process control (SPC). SBS provides on-premise and cloud-based solutions and customized software tailored to the unique needs of small businesses, improving productivity and operational efficiency. SBS offers the best value in QMS software.Starting Price: $295 -
10
DataLyzer Gage Management
DataLyzer International
DataLyzer Gage management software is 40 years on the market and is a complete webbased solution for registration and calibration of gages and Measurement System Analysis (MSA) studies. It is fully integrated in our quality suite with FMEA, SPC and OEE Features include: - Management of gages and suppliers - Internal and external calibration studies - Printing of calibration stickers. - Bias, linearity, type1,2 and 3 gage R&R studies and Kappa studies according to TS16949 or RM13003 - Planning and reports related to calibration and MSA studiesStarting Price: $1295 one-time payment -
11
ISOQualitas.PLM
ISOQualitas
ISOQualitas.PLM is an all-in-one QMS software that helps automotive suppliers efficiently capture product design, development and manufacturing information to create, print, and store quality information and documents, including Control Plans, CSRs, Work Instructions, R&R Studies, FMEA, Flow Chart, Characteristics Matrix, Inspection Reports, and many more. ISOQualitas.PLM helps standardize the entire quality management process so it is efficient and up to 80% more productive than spreadsheets, and fully complies with IATF 16949. Each quality team member can work on their individual tasks simultaneously in the office or remotely. Tasks are planned and displayed on progress charts so users and management stay up to date and can focus on priorities. Consistency is guaranteed across all documents eliminating one of the most common audit non-compliance issues. Roles are individually set for each user so information and document approval and release is controlled. -
12
Ansys medini analyze
Ansys
Ansys medini analyze implements key safety analysis methods (HAZOP, HARA, FHA, FTA, FME(C)A, FMEDA, etc.) in one integrated tool. It supports the efficient and consistent execution of the analysis activities that are required by safety standards. Ansys medini analyze is a model-based, integrated tool supporting safety analysis for safety-critical electrical and electronic (E/E) and software (SW) controlled systems. It allows for consistent and efficient application of industry guidelines, specifically tailored to industry standards, such as ISO 26262, IEC 61508, ARP 4761, ISO 21448 or MIL-STD-882E. With Ansys medini analyze, inconsistencies in the functional safety analysis are eliminated, and the certification process is accelerated. Engineers can recognize up to a 50% decrease in efforts for functional safety analysis and a similar decrease in time to market. Automate safety analysis in electronic and software systems. -
13
ReliaSoft
Hottinger Brüel & Kjær (HBK)
ReliaSoft software provides a powerful range of reliability software solutions to facilitate a comprehensive set of reliability engineering modeling and analysis techniques. We are the leading reliability solution provider for product test, design, maintenance strategy and optimization. Our products support a wide range of reliability and maintainability analysis techniques, such as life data analysis, accelerated life testing, system modelling and RAM analysis, reliability growth, FRACAS, FMEA and RCM analysis to meet and improve reliability of your products, processes and optimize maintenance planning. -
14
QAD EQMS
QAD
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. -
15
AutoDCP
Customer Driven Systems
AutoDCP also includes linking of projects or selected operations from projects into one overall composite project. This is useful for combining purchased parts, different components or generic operations with part-specific information. These types of composite projects are automatically updated when the underlying data changes. AutoDCP is the fastest most cost-effective way to maintain a linked Process Flow Diagram, FMEA and Control Plan. Risk Profiles make FMEA creation simple and fast. The FMEA drag/drop interface is easy and simple to use. AutoDCP contains several features that greatly speed up your efforts. Here are a few important ways the creation and maintenance of FMEAs and Control Plans is much faster. -
16
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. -
17
BabtecQ
Babtec Informationssysteme
Quality management software. We manufacture and offer QM solutions for all quality tasks – as we have done for 25 years. As quality specialists, we have developed an all-round solution for quality management with our modular software BabtecQ. In addition, we offer Babtec Qube, a cloud-based platform with which you can interconnect with your suppliers and customers to edit your quality tasks. Our products allow you to depict the whole range of quality processes, both internal and across companies – for quality you will love to share. Would you like to refresh your knowledge about quality management? Then you have come to the right place! On our knowledge pages you can find out, for example, what complaint management or 8D report are all about. The System FMEA (also termed a system analysis) is a subsection of the FMEA (Failure Mode and Effects Analysis). It is intended to investigate an entire system and check whether all of the individual components within it work together correctly. -
18
PLATO SCIO
PLATO AG
The PLATO software SCIO™ is especially popular with experts and moderators. The web-based software PLATO e1ns is recommended to ensure easy handling for all team members in the engineering department. It implies the most important SCIO™ functions. 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. Thanks to the database technology of SCIO™-FMEA, the requirements of knowledge management, multi-user capability and foreign language support are fulfilled. SCIO™-Matrix is the fast method of system analysis. It is used to convert customer requirements into product functionalities through optimal implementation. Complete planning and documentation of process steps. Securely stored and ready for retrieval in the SCIO™ database. -
19
AIAG-VDA FMEA
Omnex Systems
Omnex has designed AIAG-VDA FMEA Software to help companies analyze failures and mitigate risks in the process and design of FMEA phases. This software is compliant with the newly released AIAG – VDA first edition. The AIAG VDA FMEA solution is an add-on service to the revolutionary and all-time best seller AQUA PRO. AIAG VDA DFMEA provides an intuitive, easy-to-use interface to develop and manage FMEAs. Omnex believes the greatest savings in an organization will be in the design and process reuse encouraged by the AIAG-VDA FMEA via family DFMEA and PFMEA. This gap can be overcome with Omnex software. Powered with business intelligence dashboards on FMEAs, DVPRs, and more. Teams can work collaboratively in real-time on the web-based solution- available both on-premise & cloud. -
20
SoftExpert FMEA
SoftExpert
SoftExpert FMEA is enterprise software that helps companies manage Failure Modes and Effects Analysis. Through a proactive approach, SoftExpert FMEA anticipates defects before they occur, thus allowing companies to ensure quality in their deliveries. FMEA can be applied to different contexts such as products, processes, departments, assets, and lowering the engineering workload, while also improving machines and availability of resources by identifying, analyzing, and improving high-risk components. The solution continuously monitors failures identified in FMEA, by showing reports and charts with indicators such as seriousness and risk priority, which highlight causes considered to be priorities at each moment. The solution helps to enhance product safety and reliability, increasing customer satisfaction. -
21
Harpco Systems Quality Plus
Harpco Systems
Harpco® Systems Quality Plus® risk management software helps companies to systematically reduce risk throughout the entire product life cycle from definition of customer requirements through to the use and disposal of the product. Following are some of the many benefits. The key to effective and rapid risk reduction is the definition and removal of the root causes of risk exposure. Following are some of the key features that make Harpco® Systems Quality Plus® Software the most powerful software on the market at performing this task. Dynamic linking of all information from the voice of the customer to the controls on the manufacturing floor. Rapid capture of the company’s best manufacturing practices for use by all company employees. Rapid, auto-generation of risk management tools such as DFMEA and PFMEA using best design and manufacturing practice information. -
22
SPC XL
SigmaZone
XbarR, XbarS, Individuals, n, p, u, and np Charts. Update charts after they've been created. Identify outliers and have them displayed without affecting the control limiits. Histogram, Capability Analysis (Cpk), Scatter Plot (with regression fitting), Pareto, Dot Plot, Box Plots, Multiple Regression, Hypothesis Testing, Confidence Intervals, and Sample Size Calculations. Measurement System Analysis (Gage R&R) for both Quantitative and Binomial Data, Cause and Effect Diagram, Main Effects Plots, Cusum, Product Capability, FMEA, and Distribution Calculators. -
23
Quality Planning Studio
DATAMYTE
Quality Planning Studio FMEA software integrates the core quality tools and ensures adherence to fundamental process flow steps. It's a single, integrated software tool for planning, documenting and monitoring core quality requirements.For manufacturers worldwide, FMEA has become synonymous with continuous improvement programs. Process Flows, FMEA, control plan and SPC have a strong inter-relationship. The FMEA process ensures that products, processes or detection techniques are constantly improved. Continuous feedback is provided from SPC results on the shop floor to engineers responsible for the FMEA process. Quality Planning Studio FMEA software stores all data within the QPS database, ensuring traceability and integrity of your Process Flow/FMEA/Control Plan information across your plants. QPS can also communicate with our SPC software (DataMetrics), allowing you to reduce redundancy and perform characteristic capability monitoring from the Control Plan.Starting Price: $2000.00/one-time/user -
24
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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