Best FMEA Software for Windows

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

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.

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.

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.

𝗔𝗜-𝗽𝗼𝘄𝗲𝗿𝗲𝗱 𝗮𝗻𝗱 𝗽𝗮𝘁𝗲𝗻𝘁𝗲𝗱, 𝗕𝗤𝗥’𝘀 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 𝗲𝗻𝗵𝗮𝗻𝗰𝗲 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗿𝗲𝗹𝗶𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗿𝗲𝗱𝘂𝗰𝗲 𝗰𝗼𝘀𝘁𝘀. 𝗘𝘅𝗽𝗹𝗼𝗿𝗲 𝗼𝘂𝗿 𝘀𝘂𝗶𝘁𝗲 𝗼𝗳 𝟱 𝗮𝗱𝘃𝗮𝗻𝗰𝗲𝗱 𝗮𝘂𝘁𝗼𝗺𝗮𝘁𝗲𝗱 𝗲𝗹𝗲𝗰𝘁𝗿𝗼𝗻𝗶𝗰 𝗱𝗲𝘀𝗶𝗴𝗻 𝗮𝗻𝗮𝗹𝘆𝘀𝗶𝘀 𝗮𝗻𝗱 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝘁𝗼𝗼𝗹𝘀: 𝗦𝘆𝗻𝘁𝗵𝗲𝗹𝘆𝘇𝗲𝗿𝗧𝗠: streamlines PCB design with de-rating & MTBF prediction. 𝗖𝗶𝗿𝗰𝘂𝗶𝘁𝗛𝗮𝘄𝗸𝗧𝗠: verifies multi-PCB systems for errors & overstress. 𝗳𝗶𝗫𝘁𝗿𝗲𝘀𝘀®: predicts component lifespan with de-rating, thermal & stress analysis. 𝗖𝗔𝗥𝗘®: assesses reliability, availability, maintainability & safety. 𝗮𝗽𝗺𝗢𝗽𝘁𝗶𝗺𝗶𝘇𝗲𝗿®: optimizes maintenance & logistics.

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.

QT9's comprehensive cloud-based quality management software platform enables you to access real-time analytics in one unified suite. QT9 QMS makes it easy to automate ISO & FDA Compliance with 21 CFR Part 11 Electronic Approvals. Optimize processes for Document Control, CAPA's, Audits & More in one unified platform. Centralize records across multiple sites with ease. Never miss a deadline with automated email alerts/reminders. QT9 QMS makes quality management easy. Digitally transform Life Sciences, Biotechnology, Medical Device Manufacturers, Pharma, Aerospace and Food companies with user-friendly web portals for unlimited scalability. Get a free product tour! Start a Free Trial. Visit QT9qms.com

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.

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 studies

Create and edit FMEA, Process Flow Diagram, and Control Plan faster and easier than ever. FMEA is a complicated methodology, FMEA Studio has auto functions to helps you to prevent mistakes. Easy to use and easy to share your documents with another person. FMEA Studio supports many risk indexes (RPN, SOD, CN) and their evaluation methods. You can evaluate FMEA risks with 2D and 3D of risk matrixes. Ranking Severity, Occurrence or Detection level easier and faster with ranking tables. You can also customize these tables as your need. FMEA Studio can display a Structure tree of structure analysis, Function Analysis and Failure Analysis. The edit tools are easy to be accessed from right-click menu.

The Requs Suite includes software reliability prediction, software FMEA, software reliability sensitivity analysis and software reliability growth. Requs AI Predict has the only machine learning model to predict defect density in software - before the code is even written. It predicts escaped defects, failure rate, MTBSF, reliability and availability too. The Requs Software FMEA is the only intelligent software tool for software design FMEA. It determines which of the Common Defect Enumerations (CDEs) are applicable and their relative likelihood. It allows for importing of design from MBSE tools. It supports international FMEA standards and can be used for both reliability and safety analyses. The Advanced Sensitivity Analysis supports tradeoffs between reliability, cycle time, people effort, test effort. It shows which factors are most and least important for reducing defect density. The Reliability Growth Module is used during testing to trend defects and forecast MTBSF.

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.

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.

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.

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.

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.

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.