Alternatives to FMEA-Pro
Compare FMEA-Pro alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to FMEA-Pro in 2026. Compare features, ratings, user reviews, pricing, and more from FMEA-Pro competitors and alternatives in order to make an informed decision for your business.
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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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SBS Quality Management Software
Sunday Business Systems
The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server. Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - EHS module SBS Ground Control - Employee training management (LMS) - Document control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans Great product for efficient and affordable QMS Compliance -
3
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 -
4
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. -
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TenForce
TenForce
Track, analyze and report on your EHSQ processes from a single platform. Automate workflows, centralize data and simplifiy collaboration across departments. TenForce offers various integrated modules to help streamline processes such as Audits, Incident Management, CAPA, Permit to Work, Management of Change, and Shift Management. It offers mobile capabilities, which allow field workers and inspectors to access the software on mobile devices. Its built-in data analytics and reporting functionality enables managers to gain insights into the processes and risks of their industrial plants or public infrastructure assets. This visibility helps them address environmental, health, safety, quality, and compliance issues. TenForce helps manufacturers optimize their established processes while minimizing incidents.Starting Price: $9000 per year -
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 -
7
DataLyzer Qualis
DataLyzer International
Based on 40+ years experience and thousands of customers DataLyzer developed the 4th generation SPC software. SPC Qualis is a webbased statistical process control (SPC) software that simplifies the tasks of real-time data collection, charting, and analysis. Designed with the functions of manufacturing businesses in mind, DataLyzer Qualis provides powerful analysis, reports and dashboards; supports efficient data collection from any source; delivers programmable shop floor screens; and more. The solution also offers instant operator feedback, real-time data entry for both variable and attribute data, and audit traceability for IATF16949, RM13006 and ISO compliance. SPC Qualis integrates with Qualis Gage management for calibration and MSA and with DataLyzer FMEA software offering a complete APQP suite.Starting Price: $1295.00/one-time/user -
8
BQR
BQR Reliability Engineering
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. -
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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 -
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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 -
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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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Enhesa
Enhesa
Enhesa is the leading provider of regulatory and sustainability intelligence worldwide, empowering businesses to create a more sustainable future through better operations, products, chemicals, and business practices. Navigating the fast-changing compliance and sustainability landscapes is a challenge that all international businesses must face. Enhesa helps businesses meet and go beyond compliance, manage risks, and achieve sustainable business practices by translating the complexity of the compliance and sustainability landscapes into timely intelligence and foresight, creating industry leaders in safety and sustainability. Achieve compliance, manage risk, and drive sustainability. -
13
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 -
14
SpheraCloud
Sphera
Empower your business with actionable and measurable results and gain a comprehensive view of ESG performance and risk in real time. For generations, companies found it near-impossible to generate a holistic view of their risk profiles. Today, they have SpheraCloud®, an integrated ESG performance and risk management software platform. SpheraCloud is a key part of Sphera’s approach to addressing safety and sustainability issues before they even occur. It allows users to not only get the right information to the right people at the right time, but also empowers them to make better business decisions with its predictive and prescriptive capabilities. Many companies struggle to connect disparate data throughout their organizations and their value chains, and to communicate that risk efficiently and effectively. It’s hard to complete such an enormous task—without SpheraCloud. The innovative SaaS platform empowers your company to gain a comprehensive view of ESG performance and risk. -
15
Sphera Permit to Work
Sphera
Sphera’s Permit to Work software simplifies your entire workflow process. Everything is created, approved, processed, and communicated digitally and in real time. Sign-offs or approvals needed from other departments are communicated seamlessly and automatically, saving you valuable time. Enable workers to follow procedures correctly, with information that’s accessible on the go. Workers can complete tasks by referring to the permit, and managers can see completed tasks in real time. Sphera’s Permit to Work software combines real-time information from permits, isolations, hazards, maintenance shifts and SIMOPS. Managers can proactively schedule and coordinate throughout the entire facility, and dashboards offer a view of workers’ critical assignments. This holistic view gives managers access to the right information at the right time to inform their operational decisions. -
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Sphera Supply Chain Risk Management helps you proactively identify, assess and mitigate supply chain risk. You need to master supply chain risk management—we can help. The Sphera Supply Chain Risk Management Solution helps you proactively identify, analyze and mitigate all types of supply chain risk. You can turn risk into opportunity to rise above the competition—and we can help. Prevent risk from costing you by strengthening your categories with Impact Analyzer. Assess supplier criticality and detect vulnerabilities at the category. Save valuable time by making the right moves with Action Planner. Collaborate across your organization and with your suppliers to proactively mitigate risk. For certain areas of your risk exposure, your suppliers themselves are the only ones who can provide the answers. This is where you need a professional. Establish a new level of collaboration by inviting your suppliers to join you in the next frontier of supply chain risk visibility.
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17
SPHERAes
EsseQuamVideri
For over 20 years our SPHERAes software platform has been integrated with the most advanced technologies, including those of Artificial Intelligence forecasting (AI experience-based) Today the system can also be expanded with cognitive AI algorithms, Machine Learning methods for prediction, pattern recognition and risk event classification. Supporting the interpretation of legislations and regulations. Supporting the organization for asset and process management. Supporting the evaluation of business operational, economic and financial data. Supporting the integration and implementation of solutions (SPHERAes) Interfaces all existing management systems and complete eventual deficiencies. Realizes and integrates the analysis of external events and phenomena. Integrates existing management systems and covers the inevitable gaps. -
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FMEA Studio
FMEA Studio
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.Starting Price: $89 per user per month -
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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. -
20
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 -
21
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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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. -
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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. -
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PQ-FMEA+
PQ-FMEA
FMEA, Failure Mode and Effects Analysis, is a mathod whose purpose is to detect potential fault of the analyzed object, their causes and effects. It is a very effective and efficient method of supporting quality management. Work in accordance with the requirements of ISO, AIAG, VDA, AIAG & VDA. Data consistency also in the control plan and process flow diagram. Ability to create analyses: PFMEA, DFMEA and work with RPFMEA, LFMEA, MFMEA, SwFMEA, UFMEA. -
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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 -
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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 -
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AVIX Suite
Solme
Originally created as a Continuous Improvement tool, AVIX has evolved into a comprehensive end-to-end solution composed of modules designed to meet each customer's specific needs. By providing precise data and linking information across functions, AVIX helps companies streamline operations, reduce waste, and increase overall production efficiency. The basic modules in AVIX Suite are: AVIX Method - Method and time study software for process documentation & production planning. AVIX Resource Balance - Line balancing software for workload balancing between workstations & operators. AVIX FMEA - FMEA software that makes FMEA analysis easy. AVIX SMED - SMED software for changeover time reduction. AVIX DFX - Design for assembly & BOM engineering software. AVIX Ergo - Ergonomic assessment software to improve workplace ergonomics. You can buy one or more modules and expand gradually as the need arises.Starting Price: $4050/year -
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Requs AI Predict Software FMEA
Mission Ready Software
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.Starting Price: $1199/year/user -
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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. -
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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. -
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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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Daphne DMS
MRA Technologies
Document Management Software for automation of office work, collaboration, document flow, and business processes. Plans the quality control processes for incoming and outgoing goods shortens the inspection time and optimizes the cost. Provides total preventive maintenance management for equipment. Take organized notes as meeting minutes, follow-up of assigned tasks. Corrective action, 8D, GAP Analysis, Kaizen Proposals, FMEA, Ishikawa diagrams. Job Descriptions, Personnel Records, Announcements, Suggestions, and complaints. Standardize audits checklist, Records of system audits performed, 5S Inspections. Software for the creation and management of MSDSs. -
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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 -
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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. -
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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. -
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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. -
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PLATO e1ns
PLATO
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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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. -
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Q-Med Database
Sunday Business Systems
The Q-Med Database is an ISO 13485 compliant database to efficiently manage corrective and preventive actions, nonconformances, internal audit schedules and findings, safety improvement, supplier corrective actions, continual improvement projects. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Compile and analyze Customer Survey results. Document QMS review meetings and results. Cloud based or locally installed options are available. The Q-Med Database is ideal for small businesses striving for ISO 13485 compliance. CFR21 Part 11 compliant.Starting Price: $1900.00/one-time -
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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. -
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BQR CARE
BQR Reliability Engineering
Stop costly redesigns and delays caused by identifying design flaws late in the development process | Overcome challenges of managing and integrating vast amounts of data | Ensure reliability and performance of complex electronic systems | Reduce time-consuming RAMS analyses impacting project timelines | Integrate RAMS analysis tools seamlessly with existing CAD software | Gain clear, actionable insights for informed decision-making. -
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PeakAvenue
PeakAvenue
The PeakAvenue Platform is a state-of-the-art, web-based Software as a Service (SaaS) solution designed to manage the entire product lifecycle with unprecedented efficiency. It integrates functionalities from e1ns, Quality Center, XERI, and Isograph into a unified platform, allowing users to select specialized apps and methods tailored to their specific needs. It facilitates the digitalization of the product lifecycle, offering features such as a communication platform, connectivity, quality loops, an established FMEA, lessons learned processes, and supply chain transparency. Built on modern web and cloud technology, PeakAvenue ensures easy onboarding of new employees via the browser, flexible scaling for employees, methods, and apps, and hosting for software deployment and updates. It adheres to the highest IT security standards and incorporates artificial intelligence capabilities as desired. -
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CINCO
Cinco
A web based software that uses Quality Risk Management to organize, analyze and trace Quality information directly to the specific risk it represents to the patient and drug product. Why Us? CINCO, a risk-based quality management software for the Life Sciences Industry. It provides paperless traceability of every critical to quality aspect of a drug or medical device to enable transparent quality decisions at every moment. Why Risk Management? Quality Risk Management is methodology that provides an objective approach into identifying and mitigating the risks of a drug or medical device manufacturing process. It is currently required by most regulatory agencies. However, the paper-based approach the Life Sciences Industry currently uses its ineffective in managing the significant and valuable risk data. It is prone to errors, introduces too much friction to the users and ends up not adding the potential value to the operations. On-demand access to what is critical to the product qua -
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LEADER PHA
ABS Group
ABS Group's LEADER™ process hazard analysis (PHA) software has helped PHA leaders conduct and document comprehensive PHAs using the HAZOP, What-if/Checklist, FMEA, LOPA and other worksheet-oriented hazard evaluation techniques. The tool can transition between all of these analysis methods within a given study, such as a HAZOP study followed by checklist reviews for facility siting and human factors issues. Save multiple days to weeks in meeting and documentation time for a large-scale PHA. Provide up to 80 percent more accurate and complete documentation of interrelated accident scenarios. Reduce duplication of interrelated accident scenarios by up to 60 percent. Yield up to 70 percent more cost-effective analysis team recommendations that focus on improvements to the most widely applicable engineering and administrative controls. -
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Reliability Workbench
Isograph
Fully integrated reliability and safety software for the professional. Reliability block diagram analysis Fault tree, common cause and importance analysis Event tree analysis with multiple risk categories Markov analysis including multi-phase modelling Link hazard logs and requirements to RBD or fault tree verification models Multiple standards support for system analysis including ARP 4761, IEC 61508, ISO 26262 Predict the reliability of electronic and mechanical components using MIL-217, Quanterion 217 Plus, SN29500, IEC 61709, FIDES, Telcordia TR/SR, IEC TR 62380, GJB299C and NSWC FMEA and FMECA to standards such as MIL-STD-1629A, BS 5760 Part 5, GJB 1391-92, AIAG & VDA, SAE J1739, ARP5580 Link to Requirements Management tools such as Jama Connect® Our software has been in continuous development since the 1980s and is the recognized standard for safety and reliability professionals. -
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Apomatix
Apomatix
We have over ninety years of risk management and information security experience, and our products are designed to meet the unique challenges risk professionals face. Streamline and optimize your risk management activities. Identify, analyze, evaluate, and treat all your risks in one solution. Upgrade your information asset management. Record, assign, and manage your information assets in one central location. Simplify your internal control management process. Track implementation status and run control effectiveness tests for frameworks including ISO 27001 & CIS 20. We also have tools to automate the reporting process, saving you from having to manually build these in your spreadsheet. Together, these features help save time, reduce the burden of managing your risk register, and improve the quality of your risk assessments.Starting Price: $12.62 per user per month -
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InstantGMP QMS
InstantGMP
Overall, a well-implemented QMS is essential for biotech companies to achieve regulatory compliance, maintain product quality and safety, manage risks effectively, drive operational efficiency, foster innovation, and build trust with customers. InstantGMP QMS is a complete, simple, and affordable quality management system software designed by quality and regulatory experts for biotech companies. It can also apply to small-to-midsize manufacturers in a variety of industries. This quality management software has guided workflows that reinforce adherence to government standards throughout the entire production process with a diverse array of innovative features and specialized modules. Helps maintain and improve the quality and safety of biotech products. Provides frameworks for identifying, assessing, and mitigating risks throughout the product lifecycle, reducing the likelihood of quality incidents and product recalls. -
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SISA RA
SISA Information Security
Soaring cyber-attacks emphasize the need for organizations to look forward and see what is coming ahead. A formal Risk Assessment helps entities to disclose vulnerabilities and build a robust security architecture. While assessing risks is highly recommended for organizations to gain insights into the evolving cyber threats, automated risk assessment tools simplify the job for businesses. With the right Risk Assessment tool, organizations can save 70 – 80% of efforts to conduct risk-related activities and concentrate on critical tasks. SISA being a PCI Risk and Compliance expert for more than a decade, identified the challenges faced by organizations in anticipating risks and built SISA Risk Assessor, an intuitive Risk Assessment solution. SISA’s Risk Assessor is the first PCI Risk Assessment tool in the market, built based on world-renowned security methodologies, including NIST, OCTAVE, ISO 27001, and PCI DSS risk assessment guidelines. -
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Prevalent
Prevalent
The Prevalent Third-Party Risk Management Platform is a single solution that enables customers to automate the critical tasks required to manage, assess and monitor their third parties across the entire life cycle. The solution combines the following integrated capabilities to ensure third parties are secure and compliant: • Automated onboarding and offboarding • Profiling, tiering and inherent risk scoring • Standardized and custom vendor risk assessments with built-in workflow, task and evidence management • Continuous vendor threat monitoring • A network community of completed standardized assessments and risk intelligence • Compliance and risk reporting • Remediation management The solution is backed by expert professional services to help optimize and mature third-party risk management programs, and managed services to outsource the collection and analysis of vendor assessments. -
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V5 Traceability
SG Systems Global
SG Systems Global offers solutions for both Regulatedand Non-Regulated industries focused on Traceability, Batch Control, and Formula Control. Their platform integrates with ERP and MES systems to streamline production and improve quality. For Regulated Industries like pharmaceuticals and food processing, they ensure compliance with 21 CFR Part 11 and GMP standards through Electronic Batch Records (EBRs), Traceability, and Batch Control tools. Formula Control ensures accurate ingredient measurement and consistency, meeting regulatory requirements. In Non-Regulated Sectors such as manufacturing and bakeries, the same tools enhance efficiency without added regulatory overhead. The V5 Traceability system automates recipe management and batch tracking, ensuring smooth operations and quality across production stages. Their solutions reduce risks, optimize processes, and support scalability
