Audience
Quality assurance (QA) teams
About Matrix Quality
Matrix Quality (formerly Simploud) empowers life sciences and medtech organizations to streamline compliance, enhance collaboration, and accelerate innovation while maintaining strict regulatory rigor. It replaces fragmented spreadsheets and legacy systems with a single source of truth for all quality activities. The cloud-based platform is highly flexible, scalable, and secure, designed to grow with your organization. Featuring pre-configured workflows and built-in dashboards, it provides real-time visibility into quality metrics, significantly reducing validation efforts and ensuring audit readiness at a moment's notice.
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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.
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Matrix Req
Matrix Req (formerly Matrix Requirements) is a collaborative, AI-powered software explicitly built to meet the rigorous needs of medical device development. It helps cross-functional teams design, build, and launch high-quality medical devices while maintaining complete, end-to-end traceability of requirements, risks, and tests. The platform automates the cumbersome audit preparation process by generating structured documentation and trace matrices directly from live data, reducing regulatory submission timelines from weeks to days. Trusted by over 500+ life sciences companies, Matrix Req ensures that compliance is built-by-design rather than treated as an afterthought.
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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
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Total Lean Management (TLM) Software
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TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types.
Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
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Pricing
Free Trial:
Free Trial available.
Integrations
Company Information
Matrix Requirements
Founded: 2016
United States
matrixone.health/
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Product Details
Platforms Supported
Cloud
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Documentation
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