Xybion QMS

Quality Management System Overview

Xybion QMS is 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. Xybion QMS software streamlines your quality management processes so they are easily tailored to your specific operating style and business needs.

Some of the modules available:

Quality Management- Quality Policy - SOP Management – Audit – Creation & Management of Deviations - Non- Conformance Investigation -CAPA Creation, Investigation & Closure - Change Control Management - Complaint Management.

• Document Management: Document Types & Taxonomy - Audit Trail & Status Visualization - Automatic PDF Conversion & Configurable Stamping – Information Storage & Retrieval - Document Hyperlinks – Full Version Control & Document History - Controlled & Uncontrolled Document Support - Comprehensive Document Security – Attachments – Review & Approvals - Full Text & Query-based Searches - Publishing & To-Be-Read-Understood Document Integration with Training
• Risk Prediction and Ai: This solution helps with planning, executing, and reporting internal audits. It standardizes audit processes and checklists. Compliance Risk Predictor can use the internal audit results to predict business risks.
• Competency Management: Management, tracking and reporting against online, on the job, classroom & document-based training sessions - All other training activities – Online Examinations - Management Reporting for easy assessment of an individual’s performance and the evaluation of overall training effectiveness
• CAPA Management: Proactive management of Corrective Actions / Preventive Actions - Notifications & Escalations - Life cycle management and monitoring dashboards - Maintenance & tracking source of actions - Creation of action plans and associated tasks - CAPA Reports - RCA tools for 5 Why, 5W1H and Fishbone collection
• Change Management: Change request creation & tracking – Action creation & assignment
• Non-Conformances: Non-conformance (NC) quality process management - NC identification through final disposition - Tracking and reporting, CAPA launch from NC - Risk analysis with heat maps
• Internal/External audit: Internal & external audit - Operational compliance tasks - Customer and regulatory mandates - Role-based security model - Auto audit report generation
• Complaints Management: Complaint receipt, review, tracking & evaluation – Customers or external sources
• Data Monitoring and data integrity : Multi-lingual Support – File Deletion Control – Audit Trail – 21 CFR Part 11 Compliance – File & Database Monitoring – File Deletion Control – Modified Access Control - SharePoint Fraud Alerts – Secure Third-Party Vendor Applications – E-Signatures

Key additional features:

• Deploy only the functionality that you need today without disrupting your existing business operations.
• Designed for maximum flexibility and easy adoption of any organization’s unique quality and compliance processes.
• Proactively mitigates your risk exposure for proactive management of tasks and activities, particularly helpful in CAPA.