Alternatives to BabtecQ
Compare BabtecQ alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to BabtecQ in 2026. Compare features, ratings, user reviews, pricing, and more from BabtecQ 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. -
2
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
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. -
4
Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
5
SimplerQMS
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.Starting Price: $13,750/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
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 -
8
Qualityze EQMS Suite
Qualityze
Qualityze is a leading provider of cloud-based Quality Management System (QMS) and Enterprise Quality Management Software (EQMS) solutions built natively on the Salesforce platform. Designed to streamline quality processes, ensure regulatory compliance, and drive operational excellence, Qualityze empowers organizations to manage CAPA, audits, document control, training, change management, risk management, and supplier quality within a unified, scalable ecosystem. Focused exclusively on quality and compliance, Qualityze delivers purpose-built QMS and EQMS solutions without distractions from unrelated custom development. Our platform enables organizations across life sciences, manufacturing, and other regulated industries to simplify compliance with global standards while improving visibility, traceability, and accountability. Qualityze fosters a true culture of quality by making enterprise quality management intuitive, user-friendly, and collaborative.Starting Price: $30/User/Month -
9
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 -
10
MasterControl
MasterControl
Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.Starting Price: $25,000 / 1st year -
11
1factory Manufacturing Quality
1factory
1factory's Manufacturing Quality is a cloud-based and on-premises quality control software solution specifically created for manufacturing companies of all types and sizes. Powerful, reliable, and secure Manufacturing Quality by 1factory provides first article inspections, factory monitoring, quality control plans, in-process and final inspections, incoming inspections, inspection management, CAPAs, non-conformances, and more. Additional key features include running metrics calculations for Process Performance (Pp, Ppk), Process Capability (Cp, Cpk), variation / SPC control management, defect-risk monitoring, and more. -
12
CAQ.Net
CAQ AG Factory Systems
CAQ AG Factory Systems has established itself as one of the worldwide leading providers of quality management software. We have over 30 years of experience in the development and distribution of modular, multilingual, and industry-specific management solutions for small and medium-sized enterprises as well as multinational corporations. Our CAQ.Net software suite covers every aspect of computer aided quality assurance and was designed with the highest degrees of adaptability and customizability in mind. Just like a construction kit, our system allows you to pick the most suitable building blocks and thereby create the perfect solution to your individual quality management demands. Why CAQ.Net? Updates, Upgrades & Release Changes Support from QM & IT Professionals User Workshops Screencasts Conformity to Standards Information Security SaaS or On-Premises Floating Licenses Multitenancy Multilingual No-Code-Designer Validation Capability AI Assistants ... -
13
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 -
14
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. -
15
FMEA-Pro
Sphera
It’s hard to monitor quality risk without a robust knowledge management system. You need processes that efficiently identify, capture, manage and share critical documents and information. Sphera’s FMEA-Pro software offers a configurable framework for different FMEA methodologies and specialized capabilities for risk data management so you can ensure that proper controls are in place. It links critical quality information across design and manufacturing processes to help you achieve the quality your customers expect. Sphera’s FMEA-Pro software helps you improve the bottom line by implementing a consistent, standardized process to thoroughly analyze the inherent risks. Sphera’s enterprise Advanced Risk Assessment helps companies consistently identify, assess and control the impact of operational risk. -
16
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. -
17
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. -
18
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 -
19
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. -
20
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. -
21
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 -
22
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. -
23
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 -
24
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 -
25
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 -
26
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 -
27
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. -
28
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 -
29
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. -
30
SoftExpert EQM
SoftExpert
SoftExpert EQM is the most comprehensive enterprise quality management software (EQMS). It helps companies to achieve and maintain ISO 9001 certification through automated, highly interactive quality processes tailored to an organization’s specific products, operations and business practices. As a modular and scalable solution platform, SoftExpert Quality Management Software seamlessly integrates all key quality initiatives, including process mapping, documented information (SOP – standard operating procedures, work instructions and records), non-conformance reports (NCR/NCMR), corrective/preventive actions (CAPA), quality indicators (KPIs). The solution also manages supplier relations, customer complaints, quality audits, competence and training, quality risks and controls, quality inspection and statistical process control, increasing QMS agility and robustness. -
31
Paradigm 3
Interax Group
Paradigm 3 is a web and desktop-based platform designed to aid businesses in compliance management in regards to Document Control, CAPA Compliance, and Competency Tracking and Training. The software offers tools such as an event manager for incident investigations and customer complaints, tasks delivered by e-mail, audit preparations, among others. Some of the industries that benefit from Paradigm 3 are Healthcare, Manufacturing, Test Labs, and Service Industries. With Paradigm 3 it is no longer necessary to buy endless add on modules to manage all your compliance needs. Our system is made up of 4 modules with over 50 standard forms to meet all of your requirements for Quality, Safety and Environmental and by utilizing our form designer you can create new forms or redesign the ones supplied to ensure they exactly meet your needs.Starting Price: $1000.00/one-time -
32
ZenQMS
ZenQMS
ZenQMS is an AI-enabled electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO companies. The cloud-based, fully validated platform supports document control, training management, audits, supplier management, CAPA management, quality data intelligence, and compliance with FDA 21 CFR Part 11 and ISO standards. Unlike legacy systems, ZenQMS is designed for companies of all sizes to be easier to use, quicker to validate, and more effective at managing GxP activities. ZenQMS supports key quality processes, including: Document management/document control Training management and learning management CAPAs (Corrective and Preventive Actions) Deviations, nonconformances, complaints, issues, and other quality events Change controls Audit management Supplier and vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting -
33
QEdge
Sarjen Systems Pvt Ltd
Sarjen’s Quality Management Software brings meaningful digital transformation to how quality is managed across regulated manufacturing environments. More than just a system to store compliance records, it uses AI to turn quality data into actionable insights. AI analyzes trends, spots early signals of deviation, and predicts potential quality risks before they impact products or processes. Automated alerts and intelligent recommendations help teams act faster, reduce manual errors, and strengthen decision-making with context-aware guidance. With machine learning, the system continuously learns from data patterns and improves accuracy over time. By combining robust quality workflows with AI-driven intelligence, the solution enhances product consistency, accelerates investigation cycles, and ensures stronger compliance. It makes quality management smarter, more proactive, and easier for your teams to adopt and trust. -
34
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. -
35
MyBlueLabel
MyBlueLabel
Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated in your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.Starting Price: $235 per month -
36
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. -
37
QUMAS EQMS
Dassault Systemes
To bring new products to market as quickly as possible in compliance with global regulations, organizations need to standardize and automate their business processes that manage the collection, tracking and analysis of information and the resolution of related issues. QUMAS EQMS (formerly ProcessCompliance) is a cloud-based solution for Enterprise Quality and Process Management that delivers comprehensive integrated regulatory, quality and compliance management capabilities in a validated QMS environment. QUMAS’s data-centric approach allows you to flexibly manage quality content and to access and re-use all quality data, providing comprehensive visibility into Quality. QUMAS’s interactive quality dashboards provide QMS overview across business areas and quality initiatives. Reports are available for export, email and scheduling. QUMAS allows QMS departments to exchange information securely, efficiently and compliantly in the cloud. -
38
Orcanos
Orcanos
Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation. -
39
uniPoint Quality Management Software
uniPoint Software
uniPoint's Quality Management Software is a modular on-premise quality management software. Quality Management Software can integrate with other ERP systems with ease. Quality Management Software is suitable for manufacturers of any kind of product in any manufacturing mode. With Quality Management Software, users can manage processes such as document control, equipment management, non-conformances, corrective/prevantative actions, and more.Starting Price: $6000.00/one-time -
40
AssurX
AssurX
The AssurX platform is a versatile enterprise quality management system (EQMS) and regulatory compliance management platform. AssurX allows enterprises of any size or complexity to create a system that reliably communicates and coordinates quality and compliance information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. AssurX QMS software is highly configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify. -
41
TrackWise
Honeywell International
Honeywell's TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to help organizations efficiently manage quality and compliance processes. Leveraging nearly three decades of industry experience, it offers integrated modules that support various quality management aspects, including document control, training management, and corrective and preventive actions (CAPA). The platform incorporates advanced digital technologies such as artificial intelligence and machine learning to provide actionable, real-time insights, enabling proactive quality management. Its flexible, modular architecture allows for seamless integration with existing enterprise systems, facilitating rapid deployment and scalability. By streamlining quality processes and ensuring compliance with industry standards, TrackWise Digital® empowers organizations to bring products to market faster while minimizing risk.Starting Price: $200 per month -
42
CSols AqcTools
CSols
CSols AqcTools™ v2.6 allows users to dynamically display Analytical Quality Control (AQC) charts to monitor lab performance, provides paper-free, auditable investigations of control limit failures, includes comprehensive reports and reduces the time to assess and process your QC data. Customers in water, environmental, public health sector and industrial laboratories undertaking chemical, clinical and microbiological analysis will benefit from AqcTools. It provides a selection of ‘dynamic, interactive’ charts from the standard ‘individual plotted AQC points’ to charts that can use batch or daily means of data, for both current and historic data. In addition, users can plot charts for an individual analyst to support the labs on-going analyst competency checking. All of the information relating to each individual point such as date, batch number, analyst, instrument etc. is just one mouse click away. -
43
Quality Link
Quality Mapping Solutions
Inspired by people and technology, Quality Link 7 builds on our experience and proven platform for helping organizations automate processes, save money, and achieve regulatory compliance with an easy-to-use business operating solution. Quality Link delivers improved efficiency while eliminating manual paperwork with our document management. Every document you create will be stored and managed from within this module. You can print “uncontrolled” copies of your documentation from within this module, as well as perform many other document-related activities. With the enhanced organization, you’ll see clerical tasks by quality personnel reduced by up to 90 percent. Our software effortlessly converts existing documentation from your previous management system, and there’s no learning curve. But you won’t miss your favorite applications, as they can be easily integrated. With Quality Link, you can say good-bye to manual document maintenance, which requires constant monitoring. -
44
Ennov Quality Suite
Ennov
Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency -
45
SmartAPQP
Smart Factory Solutions
SmartAPQP is the connected platform for IATF 16949 manufacturers — from customer RFQ to PPAP to production. APQP, FMEA, Control Plan, MSA, PPAP, ECN, CAPA, supplier collaboration and lessons learnt all run on one Part Master, with one audit trail and one workflow engine. Most quality systems are eight tools pretending to be one. RFQs live in Excel. APQP runs in a project tracker that doesn't know about parts. FMEAs and Control Plans live in Word. PPAPs become PDF binders. ECNs travel by email. Suppliers get drawings as ZIPs. And the lessons your last program taught you live in one engineer's head. Two stories define the product. First, Quote-to-Launch: a customer RFQ arrives; Costing auto-skeletons a cost sheet from your BOM, MBOM and tooling; the quote is built on the approved sheet, internally approved, and won; the won quote auto-spawns a fully linked APQP project — FMEA, Control Plan, MSA, PSW and PPAP all running on the same parts you costed. -
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Wismatix QMS
Wismatix
We know that for a system to be used it needs to be accessible! You don’t want to wait for pages to load or searches to finish. You want to be able to add a record or get the information you need quickly and easily, whenever and wherever! Wismatix QMS lets you do just that. Based on many years of experience in auditing and implementing Quality Management Systems, we built Wismatix QMS for excellence regarding speed and reliability. Wismatix puts customer service above the rest. Not only will you have full support during the use of your online quality management system, but in the event, you no longer require the use of our system, we vow to send your data to you to upload on your own server for your use. Wismatix puts customer service above the rest. Not only will you have full support during the use of your online quality management system, but in the event, you no longer require the use of our system, we vow to send your data to you to upload on your own server for your use.Starting Price: $30 per user per month -
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Quality Connect
Montrium
Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements. -
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qmsWrapper
qmsWrapper
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. Document Control: Intuitively manage documents for enhanced traceability and version control. Cloud-Based Accessibility: Access your QMS anytime, anywhere. Electronic QMS: Embrace efficiency with digitized QMS for faster approvals and real-time updates. Audit Management: Prepare for audits confidently with scheduling, tracking, and reporting tools.Starting Price: $500/month/10 users -
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CASQ-it
BÖHME & WEIHS
Defect-free business processes lead to defect-free products. And that is exactly why CASQ-it is designed to encompass all the steps in your quality assurance and quality management processes – starting with the development process, continuing through the material process – up to and including your support processes. The advantage of CASQ-it lies right here in this process-oriented mode of operation – functionality that enables your CAQ system to adapt flexibly to your processes – and not vice versa. CASQ-it supports your quality assurance processes on their journey into the future: Quality and reliability increase customer satisfaction whilst reducing the cost of quality. Each separate CASQ-it module functions independently – enabling you to optimize individual processes and workflows within your company right from day one. Our modules can be flexibly combined – or used to create a comprehensive quality assurance system. -
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Nova-QMS
Novatek International
Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices.
