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.
Xybion QMS software ensures your organization complies with quality standards and regulations such as ISO standards, GxP, 21 CFR Part 11, financial reporting, and governance regulations (SOX, CA Bill 198).
Xybion QMS delivers a foundational set of consistent quality workflow processes that enable proactive management of tasks and activities, particularly helpful in corrective and preventive actions (CAPA).
Xybion QMS with a proprietary patented AI algorithm that is fully embedded with quality and compliance processes helps you proactively mitigate your risk exposure and apply CAPA effectively.
Xybion QMS software streamlines your quality management processes so they are easily tailored to your specific operating style and business needs.
Bringing products to market consistently to a safe standard is a difficult task — especially with the ever-changing guidelines and regulations that differ across different countries. Businesses that fail to meet quality standards and requirements may experience product recalls and repairs, loss of market share, and missed production targets. The following are the common challenges in quality management:
Xybion QMS ensures your organization complies with quality standards and regulations such as ISO standards, GxP, 21 CFR Part 11, financial reporting, and governance regulations (SOX, CA Bill 198).
Gain operational control and visibility over your quality processes by enabling 100% search capability for every word and workflow, while the embedded ECM enables the rapid creation of any report based on selected metadata or search words.
Gain real-time information from various data collection, cases, issues, actions, follow-up, complaints, audits, checklists, events, ethics and compliance, and many other business activities. This allows organizations to make more informed business decisions.
Built-in analytics allows for rapid creation of customized dashboards that enable you to manage workflows and know where each document is in its lifecycle. This will help you in audits and inspections where you can render any type of document with a full audit trail.
Granularly control and secure the activities of the different user roles within your system. All of your data and information are securely stored in a centralized repository with Xybion Quality Management Software.
Xybion Quality Management provides “One Platform” and “One Solution” to meet your immediate business demands, unique business needs, and the agility to drive each step of your organization’s strategic roadmap.
Xybion QMS can automate workflows, manage content, and integrate into existing technology environments, as well as granularly control and secure the activities of the different user roles within the system. It reduces IT support costs due to system consolidation and application landscape simplification. Also, it ensures compliance through its built-in features to support regulatory compliance with IACUC, AALAC, GLP, 21 CFR Part 11, and internal training requirements
The CAPA software module is offered as a stand-alone solution or integrated with other quality management processes.
CQRM XD Quality Management contains a comprehensive audit management module that will help you reduce risks.
Within Internal Controls Module, you can manage your control environment, risk assessment, control activities and more.
Customer Complaint Management Module is designed efficiently document, manage and control customer complaints in compliance.
The Change Management Module is a necessary component for any organizational performance improvement process to succeed.
Document Management System (DMS) supports you in holistically managing compliance-related information across an organization.
With CQRM XD’s PMO module, you can set company, department, or unit-wide objectives and tie those objectives to applicable programs.
CQRM XD Nonconformance module can replicate your workflow, recording, record keeping, and reporting needs.
With CQRM XD, you get an enterprise quality management to help you consistently and appropriately manage incidents.
The cloud-based software helps you comply with requirements for electronic signature, electronic records, and software validation.
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