Unified Cloud-Based Software for Predictive Compliance, Quality, and
Rapidly Transform your Compliance, Quality & Risk Management Systems for Today’s All-Digital, All-Remote World: Predict, Mitigate, Automate and Monitor Compliance in Real-Time. Be Always Compliance Inspection Ready
Regulated industries are required to achieve and maintain compliance status because of applicable regulatory rules and standards. In the digital world, this is no longer just a compliance requirement. It is now an essential part of doing business in the new all-digital, remote work environment. This requires Re-imagining all processes to be able to manage quality, compliance, third-party remote audits in the new remote work environments.
Re-Imagine People-Process-Technology & Data Unification To Predict and Mitigate Your Quality & Compliance Risks
Existing and legacy point solutions are not capable of meeting today's needs:
- Process standardization across business domains. R&D, Manufacturing and Commercial areas with embedded Quality, and compliance processes with data integrity.
- Continuous monitoring of systems, data, access, documents across business domains: flag non-conformances on a real-time basis
- Streamline and automate Internal and external audits and credentialing of external partners and vendors
- Utilize Artificial Intelligence and Machine Learning to establish a digital platform for Risk Prediction- Mitigation-Automation and Real-Time Monitoring for all quality and compliance processes
Xybion's CQRM XD Provides An Out-Of-The-Box All-In-One Unified Predictive Compliance & Quality Risk Management with Real-Time Monitoring Embedded in the XDP Platform.
Everything You Need For Total Predict-Mitigate-Automate-Monitor Compliance and Quality Risks In One Place. Use The Modules you Need and Rapidly Configure To Have It Your Process-Your Way
Attributes of the Unified Total Compliance & Quality Risk Management Cloud Platform
CQRM XD™ QMS Module
CQRM XD’s QMS Module Xybion Digital Platform XDP with embedded quality and compliance, compliance automation, and risk and quality management. Seamlessly connect your organization with external partners, vendors, and regulators in highly regulated work environments including the FDA.
QMS Module helps global organizations automate, manage, and control compliance and quality process flow including audit, Corrective and Preventive Actions (CAPA), deficiency, non-conformance, customer complaints, training and competency management, incident management, risk, internal control, and more. Embedded Enterprise Content Management and intelligent Business Process Management engine makes CQRM XD’s Quality Module the standard GRCQ X.0 platform for today’s all-remote, all-digital world.
CQRM XD Compliance Risk Predictor™
CQRM XD’s Compliance Risk Predictor™ helps Life Sciences companies conduct quantitative assessments of business risks. The patent-pending solution improves a company’s ability to understand current compliance status, know business risks and prioritize actions making teams more productive and reduces costs.
CQRM XD Real Time Compliance Monitoring Module
Compliance Builder™ is a real-time monitoring solution designed to enable 21 CFR Part 11 compliance, providing data integrity across IT systems such as file systems, database systems, laboratory or manufacturing instruments. By generating an audit trail and enabling electronic signatures, ComplianceBuilder allows you to securely track changes across all IT subsystems including file systems, databases, laboratory, or manufacturing process equipment. It can be configured to monitor any file-based system for changes, including additions, deletions, and file modifications.
CQRM XD: - Accreditation and Credentialing Module
Credana™ is a functionally rich, vertical accreditation solution where partners, external assessors, regulators, customers, and various bodies can all participate effectively. The seamless processing of information and tasks throughout the multi-year lifecycle includes but is not limited to:
- Accreditation applications
- Assessment planning and execution
- Scope reviews
- Documentation processing
- Billing integration
The comprehensive accreditation business management solution has allowed greater workforce efficiency, reductions in long-term IT maintenance/costs and provides greater transparency and requisite analytics to gauge performance.