Xybion QMS is a powerful cloud-based software that facilitates organizational compliance with regulatory guidelines and ensures products and processes meet the highest standards such as ISO standards, GxP, 21 CFR Part 11, financial reporting, governance regulations, and many more.

Quality Management System Modules include CAPA Management, Audit Management, Complaint Management, Change Management, Document Management, Non-conformances, Incident Management, Competency Management, Internal Controls, Programs and Objectives, IT Governance, and overall Quality Management, offering a robust framework for regulated operations. The platform emphasizes leveraging existing workflows while aligning with ISO, GxP, and 21 CFR Part 11 requirements, enabling proactive task and CAPA management.

Better Decision Making through a patented predictive AI algorithm embedded with quality and compliance processes helps organizations proactively mitigate risk exposure and apply CAPA effectively. It provides total quality management capabilities tailored to laboratories and regulated environments, with the ability to deploy only the necessary functionality today without disrupting current operations.

Common challenges in quality management, such as disparate systems and the need for audit readiness, are addressed by Xybion QMS through centralized governance, built-in analytics, and a unified cloud platform. The solution supports regulatory compliance with IACUC, AALAC, GLP, 21 CFR Part 11, and internal training requirements, promoting efficiency, cost control, and stronger compliance posture.

Distinctive Top Advantages of Xybion Quality Management Software

Always be Audit-Ready: Built-in analytics enable rapid, customized dashboards and an audit trail across documents and workflows. Enhance Security with granular role-based access and centralized data storage. Deploy Only What You Need, using a single platform to meet immediate business needs while remaining adaptable to evolving compliance requirements. Increase Visibility by enabling comprehensive search and reporting across all quality processes, driving better governance and transparency. Better Business Decisions by consolidating data from CAPA, audits, complaints, events, and other activities to inform strategic actions.

Features & Benefits

• Modular Quality Management: CAPA, Audit, Complaint, Change, Document Management, Non-conformances, Incident, Competency, Internal Controls, Programs & Objectives, and IT Governance modules enable tailored quality workflows.
• AI-Powered Compliance: Proprietary predictive algorithm embedded with quality and compliance processes to proactively mitigate risk and optimize CAPA.
• Audit-Ready & Visibility: Real-time dashboards, 100% search capability for documents and workflows, and embedded ECM for rapid reporting.
• Flexible Deployment: One platform, deploy only what is needed today, with easy adoption across diverse organizations.