Best FMEA Software in Mexico

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.