Unify quality management for global collaboration, audit readiness, and compliance
With an ever-increasing focus on patient safety, quality management requires deep insights and trend analysis to ensure rapid innovation.
The ³Ô¹Ï±¬ÁÏ Quality Cloud connects global processes, content, and functions, enabling medical device, diagnostic and therapeutic companies to effectively manage all aspects of quality in one place.
Intuitive and user-friendly, ³Ô¹Ï±¬ÁÏ Quality Cloud eliminates silos by bringing seamless cross-functional information sharing, while ensuring compliance and business agility.
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Connect Quality & Regulatory
Directly link documents and data required by your regulatory team to ensure timely submissions and registrations.
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Increase Collaboration
Align global quality processes and documentation for greater automation and operational effectiveness in a unified cloud platform.
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Gain Full Visibility and Control
A single source of truth for complete visibility and control over quality business processes - from product development to commercialization.
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³Ô¹Ï±¬ÁÏ Quality Cloud
³Ô¹Ï±¬ÁÏ Quality Cloud is a cloud platform that unifies applications including QMS, QualityDocs, Product Surveillance, Training, and Validation Management to deliver the most comprehensive solution for end-to-end quality management and compliance.
³Ô¹Ï±¬ÁÏ QualityDocs
Single, global source for all quality, manufacturing, validation, and GxP documents, including technical documentation and design history files.
³Ô¹Ï±¬ÁÏ QMS
Controls and automations for streamlining processes including non-conformances, deviations, field actions, CAPAs, audits, suppliers, and changes.
³Ô¹Ï±¬ÁÏ Product Surveillance
Simplify postmarket surveillance and proactively resolve quality issues.
³Ô¹Ï±¬ÁÏ Training
Streamline learning management courses, quizzes, and records with a single audit trail to ensure inspection readiness.
³Ô¹Ï±¬ÁÏ Validation Management
Optimize the validation lifecycle with fast and unified digital validation management
50%
reduction in cycle time from complaint to action to closure
100%
timely medical device reports, reducing the chance of FDA warning letters
90%
reduction in paperwork by centralizing data and making it widely accessible

