Best SoftExpert EQM Alternatives in 2025
Find the top alternatives to SoftExpert EQM currently available. Compare ratings, reviews, pricing, and features of SoftExpert EQM alternatives in 2025. Slashdot lists the best SoftExpert EQM alternatives on the market that offer competing products that are similar to SoftExpert EQM. Sort through SoftExpert EQM alternatives below to make the best choice for your needs
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isoTracker Quality Management
isoTracker Solutions Ltd
16 RatingsisoTracker Quality Management is a popular cloud-based quality management software (QMS) system. It is used on a worldwide basis by businesses to manage their ISO 9001, ISO 13485, ISO 22000, ISO 17025, ISO 14001 systems...plus many others. It is a modular product which can be configured to meet an organization's specific requirements and is competatively priced with superg customer support. Any module combination of Document Control, Complaints, CAPA, Audits, Training, Non-Conformance and Risk can be subscribed to. -
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Dot Compliance QMS
QMS for Life Sciences
$10,000 /Annually Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance solution includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured processes, enabling customers to deploy quickly and cost effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages. Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to quickly deploy flexible and scalable solutions. Automate core quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, Supplier Quality, and more. Our solution is fully configurable and offers seamless integration abilities, with easy adaptation and implementation of customer’s specific requirements. -
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TLM QMS Software is a powerful and robust quality, risk and material management software (QMS) which is validated and 21 CFR Part 11 compliant. TLM is a cutting-edge, all-in-one quality management system that can be customized to integrate with online CRM software, QuickBooks or ERP databases. Total Lean Management (TLM) QMS Software is specifically intended to be a low cost, highly integrated, flexible and continuously improving landscape to which specialty systems can be added where needed to create the digital business landscape that enables work flows the way your company needs them to work.
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Qualityze EQMS Suite is a next-generation Enterprise Quality Management Software. It is specifically designed for businesses to efficiently manage their quality processes, customer expectations and compliance requirements. It helps them address operational challenges so they can achieve excellence in terms of quality, safety and reliability. It comes with pre-defined templates for controlled documents, audit checklists, regulatory forms, material compliance reports and many more. Qualityze EQMS Suite is a set of 14 integrated modules that help create a closed-loop system to manage end-to-end quality from anywhere. Our range of smarter quality solutions is built on the Salesforce.com technology platform. These modules are Nonconformance Management, CAPA Management, Document Management, Change Management, Audit Management, Training Management, Supplier Quality Management, Inspection Management, Customer Complaints Management, Material Compliance Management, Forms Management, Permit Management, Calibration Management, and Maintenance Management, Forms Management and Field Safety Management. Our Quality Management solutions help create a culture of quality and continuous improvements by proactively mitigating quality issues.
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SimplerQMS
SimplerQMS
$13,750/year SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS 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, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry. -
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BPAQuality365
BPA Solutions
BPAQuality365, a QMS software, can be used in your secure Microsoft 365 cloud. It leverages tools used daily by collaborators and does not require you to change your user habits. It is modern, compatible with all devices, adaptable to your specific needs, and powered through innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, process and process maps, incident, change, risk, FMEA, SWOT, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app integrates with Teams discussions and users can ask the QMS while chatting in Teams and share QMS card with their colleagues. You can go further to achieve your Quality 4.0 goals by combining powerful AI features with best-in-class workflow automation and business intelligence. BPA's Microsoft Preferred status allows you to customize your QMS to meet your needs, share knowledge with your power users, and learn about M365 technologies. -
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QT9 QMS
QT9 Software
$2,300/year Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com -
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ComplianceQuest
ComplianceQuest
$30 per user per monthNatively built and operated on the Salesforce platform, QHSE is the fastest growing Enterprise Quality, Health and Safety Management System. Unified QHSE solutions combine EQMS with EHS to help customers of all sizes deliver high quality products and services in a safe and sustainable manner. They reduce risk, inefficiencies, and inefficiencies, while protecting their customers, employees, and brand. -
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ARMATURE Fabric
ARMATURE
ARMATURE Fabric™, allows you to manage all aspects of your accreditation, certifications, credentialing, audit quality, and compliance activities from one platform. Our software allows you to save time, work more efficiently and securely, and better serve your stakeholders. Whether you manage institutional, programmatic or specialized accreditation programs, certify individuals, products or organizations, conduct audits or assessments, or resolve non-conformances, ARMATURE Fabric can make it simpler and more efficient for both you and your stakeholders. Our cloud-based, secure software allows you to collect data in multiple methods (through online applications and audits, assessments and self-evaluations), manage your accreditation, certification, audit and compliance workflows, capture and manage documents and artifacts and identify and resolve issues; generate reports; and spot trends. -
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Qualtrax
Qualtrax
Qualtrax is a quality and compliance software program that can manage and control documentation, automate key business processes, streamline training management, manage external and internal audits, and ensure that critical industry regulations are met in real time. Qualtrax is a valuable resource in highly-regulated industries where compliance with standards such as ISO 17025 and 17020, 13485 and 9001, TNI and GFSI, FDA and FQS are required. -
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Intellect
Intellect
14 RatingsIntellect's QMS software has been proven to improve quality operations and reduce overall quality cost by up to 40%. Our apps were designed by certified quality professionals and can be easily customized with our no-code platform or drag-and-drop technology. Remote access for your team, mobile apps, dynamic workflows, analytics, reporting, and remote access are all possible with this modern and simple solution. Apps include Document Control and Employee Training, Audit Management CAPA, Nonconformance, as well as other useful features. -
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It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation. Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge. Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.
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Qualio
Qualio
Qualio is a one-stop solution for quality and compliance management. It's ideal for growing companies in healthcare and life sciences. Qualio is reliable, affordable and easy to use. It helps companies build life-saving products faster and achieve 100% ISO, GxP and FDA compliance. Qualio makes it easy for companies to manage document control, training and NCRs, audits as well as suppliers, complaints, and other tasks in one platform. -
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1factory Manufacturing Quality
1factory
1factory's Manufacturing Quality is a versatile quality control software designed for manufacturing businesses of various scales, available in both cloud-based and on-premises formats. This robust and dependable solution offers a comprehensive suite of features, including first article inspections, factory monitoring, quality control plans, as well as in-process and final inspections. Furthermore, it also covers incoming inspections, inspection management, corrective and preventive actions (CAPAs), and non-conformance tracking, among others. Additional noteworthy functionalities comprise the ability to perform metrics calculations for Process Performance (Pp, Ppk) and Process Capability (Cp, Cpk), along with managing variation and SPC control, as well as monitoring defect risks effectively. By integrating these capabilities, 1factory’s Manufacturing Quality ensures that manufacturers maintain high standards of quality throughout their operations. -
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Mango QHSE
Mango
$250 per monthIntegrating your Quality, Health, Safety, and Environmental Management systems into a Cloud-based platform and a Mobile App can greatly enhance organizational efficiency. Clients utilizing Mango for their QHSE compliance come from a diverse range of industries and are situated in various regions, including the United Kingdom, Australia, New Zealand, and South Africa. The assurance of our ISO 9001 and ISO 27001 certifications underscores our commitment to quality management and the protection of your information. By leveraging Mango, your consulting firm can unlock new recurring revenue streams while providing substantial value to your clients, setting you apart from the competition. The Cloud-based nature of Mango indicates that it represents the future of compliance management in the industry. With Mango in your arsenal, you can offer your clients a more streamlined and cost-effective approach to fulfilling their compliance requirements, all while simplifying their processes. As a widely recognized Compliance Management solution created by Mango Limited, it continues to evolve to meet the needs of various organizations. -
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TrackWise
Honeywell International
$200 per monthHoneywell's TrackWise Digital® serves as an innovative cloud-based Quality Management System (QMS) aimed at enhancing the efficiency of quality and compliance processes within organizations. Drawing on nearly thirty years of expertise in the field, it features integrated modules that cater to various elements of quality management, such as document control, training oversight, and corrective and preventive actions (CAPA). The platform utilizes cutting-edge digital technologies, including artificial intelligence and machine learning, to deliver actionable insights in real-time, which fosters a proactive approach to quality management. Its adaptable, modular framework ensures smooth integration with current enterprise systems, allowing for quick deployment and growth. By optimizing quality processes and maintaining adherence to industry regulations, TrackWise Digital® enables organizations to accelerate product launches while effectively reducing risks. This comprehensive system not only enhances operational efficiency but also supports continuous improvement initiatives across the quality management spectrum. -
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uniPoint Quality Management Software
uniPoint Software
$6000.00/one-time uniPoint offers a flexible modular quality management software that operates on-premise. This software seamlessly integrates with various ERP systems, making it highly adaptable. It caters to manufacturers across different product lines and production methods. Users can efficiently oversee processes including document control, equipment oversight, non-conformance tracking, and corrective and preventive action management, among others, ensuring comprehensive quality management. Additionally, the software's versatility enhances operational efficiency and compliance across diverse manufacturing environments. -
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Paradigm 3
Interax Group
$1000.00/one-time Paradigm 3 is a comprehensive platform available for both web and desktop use, tailored to assist businesses with compliance management focusing on Document Control, CAPA Compliance, and Competency Tracking and Training. This software provides a variety of features, including an event manager for handling incident investigations and customer complaints, email-delivered task notifications, and tools for preparing audits, among others. Industries such as Healthcare, Manufacturing, Test Labs, and Service Industries greatly benefit from the functionalities of Paradigm 3. With this innovative solution, organizations can eliminate the need for multiple additional modules to fulfill their compliance requirements. The system consists of four primary modules equipped with over 50 standard forms designed to address all aspects of Quality, Safety, and Environmental management. Furthermore, our form designer empowers users to create customized forms or modify existing ones, ensuring that every specific need is met seamlessly. This flexibility in form design enhances the platform's utility, making it an indispensable tool for businesses striving for compliance excellence. -
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QEdge
Sarjen Systems
QEdge QMS is Enterprise Quality Management Software (EQMS). It optimizes quality and ensures regulatory compliance. Enterprise Quality Management Software (EQMS), reduces the risk for quality process failures, lowers overall costs, and makes organizational processes more compliant. QEdge is an EQMS that allows companies to manage their Quality Management System in a disciplinary regulatory environment. It brings together all quality processes, such as Change Control and Deviation, Investigation and Market Complaints. OOS, OOT and Risk Assessment. Document Control activities, Training Records, and Document Control activities. QEdge, an intuitive and configurable software platform, allows for cross-functional communication and collaboration. It can interface with legacy systems and facilitates error-free, cross functional communication. -
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FORM OpX
FORM.com
Software that helps you comply with regulations. Fannie Mae, Wendy's and Walmart trust the best mobile inspection and audit platform. This will help you improve safety and accuracy. The #1 field management platform for teams, FORM OpX will transform your Excel, paper, and digital processes. FORM OpX combines advanced data gathering and configurable workflows with powerful operational insight to increase compliance in real time. To ensure compliance and team compliance, you can set up audits, inspections, or workflows. Digital forms allow you to capture data and guide teams to the right actions. Set up automated alerts and escalates to prompt corrective action when issues arise. You can save time and money by creating customizable workflows that improve processes, increase compliance, and reduce errors. -
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Scilife
Scilife
$1000Transform your Life Sciences operations by significantly enhancing the control, efficiency, and quality of your products and processes. Maintain inspection readiness consistently with our fully compliant platform, which has undergone pre-validation in line with GAMP5 standards. Gain complete oversight of your processes and documentation, allowing for perfectly customized workflows and maximized automation wherever feasible. Experience smooth operations and comprehensive traceability through our seamlessly connected modules. Our committed team is available to address any inquiries you may have at any moment. Only the finest Scilife experience meets our high standards! The Scilife platform not only streamlines but also automates and organizes every aspect of your industry, whether in Medical Devices, Pharma & Biotech, or ATMP. Click below to explore the specific Scilife modules that cater to the distinct lifecycle stages within your industry. Our software is not just equipped with all the essential quality tools you would anticipate; it also comes with numerous additional features that surpass expectations, ensuring your operations thrive. We're excited to partner with you on this transformative journey! -
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QCBD
CAMA Software
Quality Collaboration By Design (QCBD) offers a comprehensive quality management software solution tailored for the manufacturing sector. This cost-effective, Windows-compatible application streamlines the process of obtaining and sustaining compliance with various quality management standards, including ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. Developed by CAMA Software, QCBD encompasses a wide range of modules that facilitate training management, supplier oversight, process deviation tracking, document control, equipment management, and additional functionalities. With its user-friendly interface, QCBD not only enhances operational efficiency but also ensures that businesses can easily adapt to evolving quality requirements. -
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MyBlueLabel
MyBlueLabel
$235 per monthYou can now access your personal Quality Management Expert through an online platform designed for your convenience. With ready-to-use templates that can be seamlessly integrated into your organization, you can ensure efficient operations. Our offerings include comprehensive Quality Management Systems and digital solutions tailored for ISO 13485 related to Medical Devices, as well as ISO 9001 for General Quality Management, providing a robust framework for your quality assurance needs. Take advantage of our services to elevate your quality management practices to new heights. -
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Harrington Quality Management Software (HQMS)
Harrington Group International
$500/month HQMS applications, available on-premise or hosted, including Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. Robust technical capability, including, configuration, personalization, and customization, with flexible and customizable security options, any HTML5 browser, Single Sign-On, and more. Integration with ERP and other apps. HQMS across several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.. Highly secure Document Control, Audits, Corrective Action, Calibration, Training, and the HQMS Supplier Portal with personalization, configuration, customization, and integration. -
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BabtecQ
Babtec Informationssysteme
We provide quality management software solutions tailored to meet all quality-related needs, a dedication we've upheld for a quarter of a century. As experts in the field, we've crafted a comprehensive quality management system through our modular application, BabtecQ. Furthermore, we introduce Babtec Qube, a cloud-based platform that facilitates seamless collaboration with suppliers and customers for managing quality tasks efficiently. Our offerings encompass a wide spectrum of quality processes, enabling effective management both internally and externally, resulting in a shared commitment to quality you can trust. Interested in enhancing your understanding of quality management concepts? You are in the right spot! Our knowledge hub offers insights into vital topics like complaint management and the intricacies of the 8D report. Additionally, the System FMEA, also known as system analysis, is a critical aspect of FMEA (Failure Mode and Effects Analysis) aimed at evaluating the functionality of an entire system and ensuring all components operate harmoniously. This holistic approach not only enhances individual component performance but also strengthens overall system reliability. -
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CSols AqcTools
CSols
CSols AqcTools™ v2.6 offers a versatile platform for users to effectively visualize Analytical Quality Control (AQC) charts, facilitating the monitoring of laboratory performance while also enabling paperless and traceable investigations into control limit breaches. This software is particularly advantageous for clients in various sectors, including water, environmental, public health, and industrial laboratories, which engage in chemical, clinical, and microbiological testing. AqcTools features a range of 'dynamic, interactive' charts, from standard 'individually plotted AQC points' to those that utilize batch or daily averages of data, catering to both current and historical datasets. Additionally, users have the capability to generate charts specific to individual analysts, aiding in the ongoing evaluation of analyst competencies within the lab. Moreover, all pertinent details associated with each data point, such as date, batch number, analyst, and instrument, can be accessed with just a single click, streamlining the review process and enhancing overall efficiency. This innovative approach not only simplifies data handling but also significantly improves the quality assurance processes in laboratory environments. -
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Quality Link
Quality Mapping Solutions
Quality Link 7 is designed with a focus on both individuals and technology, leveraging our extensive experience and established platform to assist organizations in streamlining processes, reducing costs, and ensuring regulatory compliance through an intuitive business operating solution. By utilizing our document management module, Quality Link enhances efficiency and eliminates the need for cumbersome manual paperwork, allowing for seamless storage and management of every document generated. Users can conveniently print "uncontrolled" copies of documents and engage in a variety of document-related tasks directly within the module. This strategic organization significantly cuts down on clerical work performed by quality personnel by up to 90 percent. Our software also simplifies the transition by effortlessly converting documents from your former management system without any learning curve, while easily integrating with your preferred applications. With Quality Link, you can finally eliminate the burdensome task of manual document upkeep that often necessitates ongoing supervision, empowering your team to focus on more strategic initiatives. Additionally, the user-friendly interface ensures that all staff members can navigate the system with ease, further enhancing productivity across the board. -
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IMSXpress ISO 9001
IMSXpress
$160 per monthIMSXpress ISO 9001 serves as comprehensive software for document control and quality system management. Users can install the IMSXpress client on individual PCs or on a Windows server, which allows for distribution to users through remote desktop services as a remote application. The underlying database operates on MS SQL and can be set up on any version from MS SQL Server 2014 onward, with access to the IMSXpress application available across various network types. Options for remote access include setting up your own network, utilizing the cloud-based hosting service, or opting for an online subscription package. The system features a fully automated training module that includes self-training, integrated document training, and job descriptions, among other resources. It is designed to facilitate changes in documents, engineering, and processes, enabling users to create fillable PDF templates, populate them with data, and generate records effortlessly. Additionally, IMSXpress is useful for scheduling maintenance tasks, managing spare parts inventory, and overseeing complaints, non-conformities, risk management, and audit findings. This versatility ensures that organizations can maintain high standards in quality management while streamlining their operational processes. -
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Karminn EzyPro
Karminn Consultancy Network
$150 per monthThe EzyPro Adaptive Management system (QHSE) serves as a robust platform for merging compliance, performance, and ongoing enhancement efforts. It functions as a comprehensive solution for compliance, maintenance, and operational oversight, allowing for improved efficiency, information sharing, and collaboration among users. Featuring a modular design, it provides adaptable subscription options tailored to specific requirements. EzyPro Healthcare stands out as a Hospital Quality Management system that incorporates action tracking and dashboards to fulfill standards set by NABH and JCI, acting as a central hub for continuous improvement within healthcare facilities. Additionally, there is an option for remote consultancy services to assist with the implementation process. For the first time, a thorough maintenance management solution is paired with the QHSE Management system, aimed at prolonging the lifespan of equipment while enhancing time efficiency and equipment availability, ultimately leading to reduced expenses and increased profitability. Furthermore, the system includes QR code-assisted asset retrieval, which simplifies the management of work orders related to repairs, maintenance, or asset transfers, making it an invaluable tool for organizations. This innovative approach not only streamlines operations but also fosters a culture of accountability and excellence within the organization. -
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Effivity
Effivity Technologies
$30 per monthEffivity is a cloud-based or on-premise QHSE/FSMS/ISMS program that helps you implement a robust Quality – Occupational Health & Safety – Environment Management System. It conforms to all ISO 9001, ISO 14001 and ISO 45001 standards. Effivity makes ISO compliance easy, quick and cost-effective. It also allows for collaboration and time-savings. This is validated by more than 120 countries. -
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NiftyISO
Niftysol
$9 per monthNiftyISO 9001 Audit software simplifies the process of quality management by guaranteeing compliance, boosting efficiency, and maintaining consistency throughout your organization. Available on various platforms, including the web, mobile devices, and tablets, it enables you to enhance quality from any location, thereby improving operations regardless of whether you are working in the office or remotely. This versatility allows teams to stay aligned and focused on quality objectives, leading to better overall results. -
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Mobile app is the complete solution to auditing and inspections. The most efficient way to raise your standards and improve your quality scores! Mobile inspections and audits can be conducted on any device. Even offline. Automatically generate PDF reports that are engaging, informative, and engaging for each inspection. Corrective actions close the loop. Our advanced analytics dashboard gives you unprecedented insight into your operations and optimizes your ROI.
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QwizPRO
Telonic IQ
$199 per monthQwizPRO revolutionizes quality management for compliance with ISO 9001 and AS9100, making audits effortless and efficient. By utilizing its intuitive automation, the platform reduces errors, conserves time, and enhances the compliance journey. In the fiercely competitive landscape of modern business, QwizPRO is crucial for achieving quality excellence without complications. It enables consistent monitoring and assessment of suppliers, ensuring they meet your rigorous quality standards. Featuring real-time analytics and customizable reporting options, the software provides insightful visibility into supplier performance, showcasing strengths while pinpointing potential vulnerabilities. Equip your team with tailored QMS training that progresses from a basic grasp of industry standards to a comprehensive understanding of intricate procedures. QwizPRO facilitates automatic training deployment, tracks learning advancements, and uncovers areas needing improvement. Additionally, the software ensures immediate access to essential documents necessary for daily operations, further optimizing productivity and efficiency. With such capabilities, QwizPRO stands out as an indispensable tool for organizations striving for continuous quality enhancement. -
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QualityKick
SoftDoit
QualityKick is a cloud-based Quality Management System (QMS) tailored for the biological sciences sector, designed to enhance compliance and streamline various quality management processes. It offers a suite of modules, each addressing critical components such as document control, training, change management, incident tracking, CAPA (Corrective and Preventive Actions), risk evaluation, qualification, and supplier and equipment audits. Being a web-based platform, it ensures accessibility from any location and on any mobile device, including computers, smartphones, and tablets. New users benefit from an automated guided tour upon their initial login, facilitating a smoother onboarding experience. The system supports document editing with MS Word and enables a customizable review and approval workflow, enhancing collaboration and efficiency. Various event types, including deviations, nonconformities, and customer complaints, can be configured to suit organizational needs. Additionally, it allows users to establish CAPA plans, document necessary actions, and assess their effectiveness, making it a comprehensive solution for quality management in the pharmaceutical, biotechnology, and medical fields. With its user-friendly interface and robust features, QualityKick is poised to transform how organizations manage quality compliance. -
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ISO2HANDLE
ISO2HANDLE
$0Are you a risk or quality manager in search of a powerful solution to your problems? ISO2HANDLE gives you superpowers to control your quality, safety and HR processes. ISO2HANDLE can be used by businesses in any industry. Our software provides capabilities such as risk and resource management, complaint management (including task management), risk assessment, registrations and notifications, document management (including audits), onboarding, evaluations of employees, expense claims, leave requests, and environmental measures. You can generate reports with just one click. This makes audits easy. We are proud to support hundreds of companies around the world from our base in the Netherlands. -
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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. Best For 1. For companies who need guidance to implement and adopt validated QMS. 2. For companies who want to automate their quality management and go beyond a paper-based system.
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Conformance Works
Conformance Works
Every organization's structure is distinct, necessitating a tailored strategy to address issues related to international regulations. This process can often be quite time-consuming. To meet these challenges, ISMS Solutions has developed Conformance Works, a unique platform designed to guide users through an automated process that helps them achieve compliance with the specific ISO standards they require. In essence, Conformance Works makes the certification process more efficient and personalized for each entity. Featuring an integrated document management system, a global change editor, a compliance management system, and a risk assessment module, the platform ensures that company documentation is both clear and effective. The software is designed to be accessible across various digital channels, facilitating quicker implementation of ISO standards for certification. Additionally, it provides a smooth user experience, enabling organizations to efficiently meet or surpass ISO requirements while minimizing administrative burdens. By leveraging this tool, companies can not only streamline their compliance efforts but also enhance the overall quality of their management systems. -
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QUMAS EQMS
Dassault Systemes
To expedite the introduction of new products while adhering to international regulations, companies must streamline and automate their processes for gathering, monitoring, analyzing information, and addressing related challenges. QUMAS EQMS, previously known as ProcessCompliance, is a cloud-based platform designed for Enterprise Quality and Process Management, offering extensive integrated solutions for regulatory, quality, and compliance management within a validated Quality Management System (QMS) framework. By leveraging QUMAS’s data-centric methodology, organizations can adeptly manage quality-related content and easily access and repurpose quality data, ensuring thorough visibility into the quality landscape. Furthermore, QUMAS features interactive quality dashboards that provide an overview of QMS performance across various business sectors and quality initiatives. Users can generate reports that are easily exportable, shareable via email, or scheduled for regular updates. This platform also facilitates secure, efficient, and compliant information exchange among QMS departments in the cloud, enhancing collaboration and operational efficiency. Ultimately, QUMAS empowers organizations to meet their quality objectives while navigating the complexities of regulatory compliance. -
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Ennov Quality Suite
Ennov
Ennov Quality Suite. A comprehensive QMS to increase efficiency and ensure compliance. Ennov Quality Suite Ennov Quality Suite combines the power of Ennov Doc and Ennov QMS with Ennov Report and Ennov Training to create an integrated quality management solution that improves operational efficiency and ensures compliance to industry standards like 21 CFR Part 11, GxP, and ISO. Ennov Quality offers a predefined inventory that includes quality documentation, processes, and workflows. These are based on industry standards and best practices. Ennov Quality customers can quickly get their system in production and begin to realize their return on investment. Ennov Quality, as all Ennov solutions, is easy to set up and requires no IT skills. A unified and intuitive content and information management platform that supports and enriches the entire Life Sciences product cycle. Our comprehensive QMS improves operational efficiency -
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NWA Quality Analyst
Northwest Analytics
NWA Quality Analyst®, an award-winning SPC charting and analysis solution, is the best. It offers the best combination power, flexibility, ease-of-use, and flexibility of any SPC software. It allows users to visually analyze process behavior and evaluate the impact of process improvements. -
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CASQ-it
BÖHME & WEIHS
Ensuring that business processes are free of defects results in the creation of products without flaws. This is precisely why CASQ-it has been developed to cover every phase of your quality assurance and management procedures, beginning with the development stage and extending through material handling, all the way to support processes. The strength of CASQ-it is found in its process-oriented approach, offering a feature that allows your CAQ system to adjust seamlessly to your specific workflows rather than forcing your operations to conform to it. CASQ-it paves the way for your quality assurance efforts to advance into the future, enhancing quality and reliability, which in turn boosts customer satisfaction and lowers quality-related costs. Each CASQ-it module operates independently, allowing for the immediate optimization of distinct processes and workflows within your organization. Moreover, these modules can be combined in various ways, or utilized to form a holistic quality assurance framework tailored to your needs. Embracing this flexibility facilitates continuous improvement and fosters innovation within your quality management practices. -
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ACE Essentials
PSC Software
$500 one-time payment 2 RatingsACE Essentials is the pre-validated Electronic Quality Management System Software (EQMS) designed for highly regulated industries. ACE Essentials includes 10 workflows, as well as all the required Standard Operating Procedures (SOPs) and Policies. This ensures that your quality management system is fully compliant from the start. ACE Essentials features include a complete audit trail that tracks every action within the system. This allows you to understand the risks associated assets. Features of ACE Essentials Pre-Configured Workflows Pre-Configured Event Management (Due dates, Scheduling, Reminders) - Pre-Configured Permission Based Security - Pre-Configured Full Documentation - 50+ documents - Multiple Site Capability - No Charge Upgrades for the Product's Life Pre-Configured Tasks Liste - No Validation Period Pre-Configured In System Notifications Pre-Configured Email Notifications -
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Quality Connect
Montrium
Cloud-based Enterprise Quality Management Software tailored for the life sciences sector is essential in navigating today’s intricate operational landscape. With technology at the forefront, it ensures that quality assurance teams are promptly informed of issues as they arise, fostering a culture of proactive management. By gaining a clear view of the quality management system's performance alongside operational conditions, organizations can significantly reduce risks and avoid expensive delays. Montrium has crafted its Enterprise Quality Management System (EQMS) specifically to help life science companies confront their quality management challenges directly, particularly in content management. Our SharePoint QMS modules are designed for flexibility; they can function independently or as part of a cohesive quality management system. These modules are accessible through our Montrium Connect Platform and can be implemented either on-premise or via cloud solutions, making them ideal for pharmaceutical firms, contract manufacturing organizations, and medical device companies. Each component is meticulously built to ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), thereby supporting organizations in maintaining the highest quality standards. Ultimately, this comprehensive approach not only enhances efficiency but also strengthens the overall integrity of the quality management process. -
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Greenlight Guru
Greenlight Guru
Greenlight Guru is the only product development and quality management platform designed specifically for medical device companies. The Medical Device Success Platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance, and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control, and more. Device makers across the globe are replacing their outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality. -
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AssurX
AssurX
The AssurX platform is a powerful software platform for enterprise quality management (EQMS) and regulatory compliance to reliably communicate and coordinate information, documentation, and activities. AssurX allows regulated businesses to quickly identify and control quality issues and risk exposure to avoid quality or noncompliance problems while improving workflow. AssurX QMS software is uniquely 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. No other system is easier to deploy, configure, and modify. AssurX solutions integrate seamlessly to create a connected quality system. Solutions include audit management, corrective actions, training management, compliant management, document management, change control, risk management, EHS incident management, and more. -
46
QM
SOLABS
Document control made easy. You can create, review/approve and revise documents, as well as retire them. All transactions are recorded using e-signatures, timestamps, and stored in the Audit Trail. Audits from start-to-finish The SOLABS QM10 Audit APP allows you to track and document all aspects of your audits, from planning and preparation to closing. The SOLABS QM Essentials package offers advanced reporting capabilities and intuitive reporting. Trending and tracking are critical components of any quality management system. The dashboards and reports are easy-to-use, customizable, and can be shared in the most popular formats such as Excel, PowerPoint and PDF. You can share the reports and dashboards with anyone in your organization. In a matter of seconds, you can create, schedule, monitor, and assign training. Online assessments can be used to validate the learnings of your team. You can manage all aspects of training with the SOLABS QM Training section. -
47
DELMIAworks
Dassault Systemes
To optimize your shop floor, combine manufacturing, MES and supply chain software. Learn how DELMIAworks, formerly IQMS, can help you improve visibility into every aspect your manufacturing operation and solve the most difficult production problems. Reduce downtime and increase manufacturing efficiency, quality, profit margins, and quality. Real-time data access across the entire supply chain can improve decision making. All ERP, manufacturing, MES and supply chain requirements can be handled by one system. Automating your business can lower your investment and maintenance costs. Our simple-to-use solution will double your plant output, eliminate human error, and improve the efficiency of production planning. To eliminate unplanned downtime, increase throughput and reduce downtime, manage, track and monitor all aspects of the production process. OEE graphs and charts are dynamically updated with performance data and quality data in real time. -
48
Cority
Cority
These proven solutions will help you operationalize your pandemic response plan, monitor and report on your employees' and visitors' health, and increase your business' productivity. Engage employees, improve workflows and increase data visibility at all levels of your company to improve safety culture. Cority helps you to break down silos within departments, improve reporting, achieve operational excellence, and increase productivity. Cority's unified compliance management system is designed to take the guesswork out compliance. myCority connects your frontline employees, no matter their location, with the tools they need in order to reduce risk and drive compliance. EHSQ experts develop, implement, and support the Cority solution. We are the industry leader in Occupational Health, Industrial Hygiene and Employee Health solutions. You can take your safety programs to the next step by proactive mitigating risks, managing compliance and reducing incidents. -
49
SmartSolve
IQVIA
$542 one-time paymentStreamline tedious and repetitive tasks so you can concentrate on delivering products that are both safer and more effective, and do so at a quicker pace. IQVIA’s SmartSolve Postmarket Surveillance offers a comprehensive SaaS solution for postmarket surveillance (PMS), equipping you with best practices for the centralized management of all PMS activities. The Fusion event, tailored for SmartSolve and RIM Smart users, provides extensive education on pertinent quality and regulatory subjects, offering actionable insights and practical tools applicable across any Life Sciences organization. Initially launched as a live conference for SmartSolve users, Fusion has transformed over recent years to encompass both virtual and in-person events for the broader SmartSolve and RIM Smart communities. Enhance your compliance response times, accuracy, predictive planning, and overall efficiency through the IQVIA SmartSolve™ Regulatory Connector. This Connected Intelligence framework represents our forward-thinking, integrated strategy aimed at fostering significant operational efficiencies across the board, ultimately benefiting your organization in numerous ways. Embrace these advancements to ensure your organization remains competitive in a rapidly evolving landscape. -
50
Veeva Vault QualityDocs
Veeva Systems
Vault QualityDocs enhances quality processes and mitigates compliance risks through automated workflows and thorough audit trails. By streamlining review and approval procedures, it ensures efficient sharing of SOPs and other GxP documents among staff and collaborators. The automation of workflows, coupled with real-time visibility into content status, empowers organizations to manage SOPs effectively, further minimizing compliance risks. Its user-friendly interface promotes higher adoption rates and operational efficiency. In addition, the system provides detailed audit trails, organized content, and robust search capabilities that greatly improve audit preparedness and inspections. Users can securely access and interact with documents via any major web browser, and if configured, can print, distribute, and monitor controlled PDF copies. The incorporation of predefined document taxonomies, metadata, and selection lists for quality, manufacturing, and validation documents not only streamlines operations but also enables organizations to swiftly embrace industry best practices, ensuring continuous improvement and compliance alignment. Thus, Vault QualityDocs stands as a pivotal tool in modern quality management.