Xybion QMS is purpose-built for today's digital world, embedding quality, risk, and compliance management for the entire enterprise within a single SaaS platform. It is designed from the ground up for highly regulated industries that necessitate strict, evidence-based documentation of activities for compliance, safety, and liability management. With its multiple modules and a built-in configuration engine, Xybion QMS can be quickly adapted to suit the exact needs and operating style of any business. The platform features a rapid QMS configuration engine, enabling users to deploy only the specific modules required for their operations. These modules are configured using built-in tools, offering significant flexibility in the system's look and feel. This rapid configuration capability solves the "last-mile problem" by allowing configuration changes to be delivered within days, avoiding the need for manual workarounds or custom coding. As a cloud-based SaaS solution, Xybion QMS is easily configured and deployed, scaling to fit even the largest global enterprise deployments. It is designed for maximum flexibility, adapting seamlessly to any organization's unique business processes. Additionally, Xybion QMS can manage all stakeholders, including customers, partners, external contractors, governing bodies, and various internal groups, along with their contacts, organizations, and locations. It automates workflows, manages content, integrates into existing technology environments, and provides granular control and security for different user roles. The system reduces IT support costs through consolidation and simplification of the application landscape, and ensures compliance via built-in features supporting regulatory requirements such as IACUC, AALAC, GLP, and 21 CFR Part 11, as well as internal training requirements.

Features & Benefits

• All-in-One Digital QMS
  • Provides a standalone, all-in-one digital Quality Management System with embedded quality, risk, and compliance for the entire enterprise in a single SaaS platform.
• Purpose-Built for Regulated Industries
  • Designed for environments requiring strict evidence-based documentation for compliance, safety, and liability management.
• Rapid Configuration Engine
  • Enables quick adaptation to business needs, allowing users to deploy only specific functionality and configure it using built-in tools, avoiding custom coding and manual workarounds.
• Comprehensive Module Suite
  • Offers a wide range of modules to manage various quality processes.
  • CAPA Management
  • Audit Management
  • Complaint Management
  • Change Management
  • Document Management
  • Non-Conformance Management
  • Incident Management
  • Competency Management
  • Internal Controls
  • Programs and Objectives
  • IT Governance
  • Quality Management
• Enhanced Compliance & Regulatory Adherence
  • Ensures compliance with standards and regulations including 21 CFR Part 11 on electronic records and signatures, ISO standards, GxP, financial reporting, governance regulations, IACUC, AALAC, and GLP.
• Scalable Cloud-Based Solution
  • Easily configured and deployed, scaling to fit even the largest global enterprise deployments while offering maximum flexibility to adapt to unique business processes.
• Automated Workflows & Integration
  • Streamlines quality management processes by eliminating disconnected systems, reducing manual data entry errors via automated processes, and integrating into existing technology environments.
• Centralized Stakeholder Management
  • Manages all stakeholders and their contacts, organizations, and locations, including customers, partners, external contractors, governing bodies, and various internal groups.
• Reduced IT Support Costs
  • Achieved through system consolidation and application landscape simplification.