Quality management software (QMS) helps businesses assess and maintain the integrity of produced goods and customer experiences. A QMS typically delivers features such as inventory inspection records, documentation and reporting related to undesirable events (e.g. complaints, defective merchandise), corrective or preventive action forms, and process automation assistance to minimize deviation. QMS tools often integrate with product lifecycle management software, and many products integrate with or provide some features of governance, risk, and compliance software to ensure equipment, working conditions, and processes meet necessary regulations. Manufacturing and supply companies can utilize QMS products to audit the production process from start to finish, avoid a wide variety of potential hazards and issues, and increase revenue through repeat business from satisfied clients.
To qualify for inclusion in the Quality Management Software category, a product must:
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Greenlight Guru is the only quality management platform designed specifically for medical device companies. The 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 Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance achieving True Quality. For more information or to request a demo, visit http://www.greenlight.guru.
5 of the largest worldwide regulatory agencies use MasterControl. Their Quality Management software enables your company to get your products to market faster at reduced cost, and increased efficiency. Average estimated first year savings for a complete QMS reported at $248,565. As the only automated TOQ provider MasterControl has deployed their software across 1,000 customers and 30 countries. Discover how you can automate your CAPA, Document Control, Training, and other QMS processes.
For a 5-minute demonstration of COMPASS, go to www.creato.com/compass COMPASS is a project portfolio management system that collects and ranks ideas, allows management to engage in feedback with employees to improve ideas, rescore ideas, and approve ideas. Once ideas become projects, COMPASS will guide the end user with just-in-time tools and training. Tools are extensive and include descriptive and inferential statistics in addition to simple brainstorming tools. Training is derived from the ASQ Lean Body of Knowledge. COMPASS will always recommend the best tools and best training based on the status of the project. Reporting is extensive and includes the ability to send alerts to staff based on projects approaching milestones, running behind, or missing data. COMPASS also includes full integration with SharePoint including single sign on, for purposes of indexing work and accommodating a variety of file formats. Finally, COMPASS promotes collaboration by sending project updates automatically to all stakeholders. Finish more projects, finish more projects faster and finish projects with greater returns with the COMPASS Quality Management System. COMPASS was recognized by CIO Magazine as one of the "Top Quality Management Systems" of 2017 and 2018.
Beacon Quality is the integrated, intuitive, mobile audit and inspection tool that reduces administrative overhead and gives organizations full visibility into their Layered Process Audits (LPAs), safety, corrective actions and other process programs. Process Audits: review that processes are being followed and easily report your findings on Layered Process Audits, 5S, Safety Audits, and more. Equipment Inspections: inspect assets and facilities to identify corrective action opportunities. Corrective Actions: correct real-time or automatically assign a responsible party. With Beacon Quality, you can: -Upload photos or documents right from your phone or tablet; -Take photos real-time with your phone or tablet & instantly upload; -Responsible party workflows are automated based on the question & area it relates to; -Wifi & Off-line capabilities allow you to audit anywhere; -Access levels & permissions means questions, scheduled audits, and reports are accessible to only those with the right permissions; -Custom branded mobile app & portal with your logo & brand; -Reporting dashboards & reports with drill-down into reports to see the finer detail, or download for more reporting options.
Qualio is modern quality management software (QMS) that unites your team, tools, and data. Designed for life sciences companies (medical device, pharma, biotech, and contract organizations) who develop, produce and distribute life-saving products and services. Crush Audits Always be audit-ready with full visibility and control over what's happening anywhere in your system. Quickly identify issues and close gaps to ensure activities are scheduled and completed on time. Eliminate Defects Identify and resolve issues before they become problems. Powerful reporting and alerts help identify problems early so that you can react quickly. Collaborate to investigate root causes and complete CAPAs in record time. ... and see Quality-Driven Growth Enjoy quality-driven growth through happy customers, reduced product issues, fast time-to-market, real-time visibility and control, rapid revenue growth and a healthy bottom line. Achieve 100% FDA/ISO/GxP compliance in audits. Qualio automates the painful paperwork and processes required by regulators for 2x faster accreditation/approval. Work 5x faster than paper/traditional solutions to manage Document Control, Training, NCRs, CAPAs, Audits, Suppliers, Complaints and more.
Intellect offers the industry's most configurable enterprise Quality Management Software (eQMS) suite and platform. Lower your total cost of ownership, reduce product recalls, and improve operations by easily modifying your applications to meet your exact requirements using Intellect's no-code platform. Learn how you can effectively and efficiently manage your Nonconformance, CAPA, Document Control, Change Management, Audit, Training, Risk Management and many other QMS and business processes.
TrackWise software by Sparta Systems is an enterprise quality management solution (EQMS) that optimizes quality, ensures compliance, reduces risk, and lowers costs for world-class clients across a range of industries. Commonly known as QMS software, TrackWise software is the only enterprise quality management solution that offers the flexibility and configurability to adapt to company-specific requirements and business processes, enabling our clients to define, track, manage, and report on the core activities vital to their success.
EtQ is the leading quality, EHS and compliance management software provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration. EtQ provides a compliance management platform that enables organizations to implement compliance processes, create new processes and automate and control their compliance ecosystem. Core solutions include Corrective Action, Risk Management, Document Control and Employee Training.
Propel's enterprise cloud software is the innovation platform for future brands. We offer the world's only integrated Product Lifecycle Management (PLM), Product Information Management (PIM) and Quality Management Systems (QMS) solutions that help all your employees, partners and customers deliver your best ideas to market. Propel has developed the only integrated PLM, PIM and QMS solutions built on the Salesforce platform — the world’s most secure, trusted and flexible cloud platform. Our SaaS PLM, PIM and QMS software helps everyone collaborate better on all the product information needed for market success, and only takes a few weeks to get up and running.
Quality & Project Management for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success. qmsWrapper integrates 5 separate software into 1 complete cloud based system, including Project, Risk, Document and Quality Management modules with built-in Team Messaging for the best Collaborative Compliance experience. Quality managers with little experience can easily step into the role and effectively start. Create safer, better, medical devices and get them to market faster.
1factory provides easy-to-use yet powerful Manufacturing and Supply Chain Quality Control software. With 1factory, manufacturers can control product quality within their factories and across their supply chains. Features include: 1. PDF Drawing Ballooning, First Article Inspection, AS9102 2. Quality Control Plans 3. Incoming, In-Process, Finished Goods Inspections 4. Digital Gage, CMM, and Test Fixture Data Import 5. Process Capability (Cp, Cpk, Pp, Ppk) 6. SPC, Run Charts, Histograms 7. Traceability: Batch Number, Serial Number, Gage, Inspector 8. Factory Defect Risk Monitoring 9. Non-Conformances, Corrective Actions, Audit Findings 10. Gage Calibration and Tracking
InfinityQS quality solutions, powered by our industry-leading SPC engine, deliver unparalleled visibility and intelligence. With our solutions, manufacturers gain strategic insight to make data-driven decisions that improve product quality, decrease costs and risk, and meet compliance requirements. InfinityQS enables manufacturers to convert quality from a problem into a competitive advantage
TrackWise Digital offers a suite of quality and compliance solutions on a centralized, validated platform.Built on over two decades of experience, TrackWise Digital combines out-of-the-box best practices processes with the flexibility and scalability of the Salesforce platform. The agile cloud system can be quickly implemented, easily updated and accessed on any device. With reporting and analytics across all quality processes, users can leverage quality data to strengthen their culture of quality and impact company-wide performance. Key Benefits: Ensure Regulatory Compliance Create Powerful Business Insights Increase Workforce Efficiency Create a Culture of Quality Key Features: Out-of-the-Box Workflows Pre-Validated Releases 21 CFR Part 11 Compliance Electronic Signature and Audit Trail
The AssurX platform is a versatile system of software solutions for quality management and regulatory compliance to reliably communicate and coordinate information, documentation and activities across the enterprise. AssurX allows regulated businesses to easily identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. It is uniquely configurable to fit any established or dynamic business requirements. The AssurX system creates an electronic workflow of tasks, alerts, escalations and approvals that can be automated to the desired level and mapped 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.
Compact.Net is the definitive tool for flexible and state-of-the-art inspection planning, inspection data gathering, evaluation, and analysis. It is your one-stop-solution for process-accompanying inspections, SPC, CAD, and incoming/outgoing goods inspections: Compact.Net provides you with everything you require for comprehensive and sophisticated quality assurance and its clear information structures and superior usability provide invaluable assistance throughout the fulfilment of key requirements of ISO 9001, IATF 16949, ISO 13485, IFS, GxP, EN 9100, and further standards and regulations.
CASQ-it is a synonym for systematic defect prevention – prevention that starts in the early development process. Right from the initial product design phase, our CASQ-it modules support your project management processes, risk assessment and process planning activities and your gage management right through to the production process and product approval stages.
The Cockpit Platform is a validatable environment for product development. Cognition offers the Cognition Validation Kit, which enables companies to confirm the validation of the Cockpit Platform against GAMP 5 and AAMI TIR36-2007. You can either validate on your own or use Cognition's Validation Services to ease the burden
Donesafe is Health, Safety, Quality and Environment software that connects your management system from workers in the field to the management team in the boardroom. Donesafe makes it fast and easy to access, enter and report EHS data in real time. Donesafe is a modern & fresh platform with end to end functionality. It works online with any device, including offline with native iOS and Android apps. Use our out-of-the-box templates or configure to align with your specific requirements.
EMEX - a modular web-based platform that centralises, integrates and automates the management of EHS compliance. Scalable, configurable and designed to meet the needs of dynamic businesses it is truly flexible and allows specific business rules for different divisions and business units throughout an organisation. The configuration toolset available on the platform provides advanced capabilities such as Workflow design, Web Forms configuration and Report & Business Intelligence design. These toolset's along with the flexible application set-up allow organisations to rapidly implement best-practice for all aspects of EHS compliance.
The Ennov Quality suite is a single, unified QMS for managing Quality documents, processes and training. Ennov QMS ensures the highest degree of traceability, knowledge sharing and compliance throughout your company. With Ennov Quality, you can from a single user friendly interface: - Create, manage and control your Quality documents using the most intuitive Electronic Document Management System on the market. - Manage and track all your Quality data and processes (CAPA, Deviations, change control, audits...). - Automate the management of training programs for new employees and simplify audits. More than 400 organizations worlwide use Ennov Quality, especially Life Science companies (pharmaceutical, medical devices, biotechnology, chemical, cosmetics, CROs). Ennov Quality complies with 21CFR part 11. Ennov Quality's configuration is extremely easy to modify without any IT knowledge (no programming required), which enables to deliver your Quality solution in record time and according to your specific needs. It also enables to train you so that you can become fully autonomous in modifying the configurations (for instance in creating a new process or a new document type if needed). This enables our customers to become more agile while maintaining the highest quality standards.