Ecosystem Architecture
Quality Management System
All quality, manufacturing, and regulatory processes connected in one unified ecosystem. Explore the interactive architecture wheel or inspect the executive compliance workspace.
Executive Architecture Workspace
Interactive Process Cockpit
A structured executive environment. Navigate by Strategic Pillars with live inspection dossier or switch to the Regulatory Compliance Matrix.
Modules in this Pillar5
#01Roadmap
Quality Management System (QMS) Documents
ISO 13485:2016 pkt 4.2.4 & 4.2.5#09Roadmap
Change Control
ISO 13485#08Active
CAPA
ISO 13485:2016 pkt 8.5.2#07Roadmap
Internal Audits Management
ISO 13485:2016 pkt 8.2.4#06Roadmap
Complaints, Feedback & Post-Market Surveillance
ISO 13485:2016 pkt 8.2.1 & 8.2.2MODULE #01Roadmap 2027
Quality Management System (QMS) Documents
Automated SOP, work instruction, and Quality Manual control with zero paperwork.
Regulatory Clauses
4.2.3, 4.2.4, 4.2.5 (Documentation & Records)
Annex IX Chapter I (QMS)
Generated Quality Artifacts
SOPs, Quality Manual, Audit Trail
Core Automated Capabilities
Automated version control for SOPs, work instructions, forms, and the Quality Manual
Configurable multi-stage review and approval workflows
Electronic signatures with audit log
Automated document distribution and revision-read notifications to personnel
Connected to all other modules in a unified database
Module coming soonHave questions?
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