Unified Cloud Based Software for Predictive Compliance, Quality, and Risk Management

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 in view 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, and 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 System with Real-Time Monitoring Embedded in the XDP Platform.

Total Compliance Risk Management

Everything You Need to Predict, Mitigate, Automate, and Monitor Compliance and Quality Risks in One Place.
Use The Modules You Need and Rapidly Configure Them to Achieve Your Process-Your Way.

Total Unified Predictive Compliance & Quality Risk Management Solution

Fully integrated, modular platform addressing all aspects of Governance, Risk, Quality, Compliance, Enterprise, and Operational Risks, Accreditation, Third Party Audit, and Risk Management.

CQRM XD Risk Prediction
CQRM XD Continuous Monitoring

Attributes of the Unified Total Compliance & Quality Risk Management Cloud Platform

Patented Algorithm Predicts Your Risk Exposure

Complete Quality Management System

Accreditation and Credentialing

Actionable Results

Predict Compliance Risks Prior to Audits

Plan and Execute Compliance Audits

Risk Mitigation

Built-In Enterprise Content Management


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.

Compliance Quality Risk Management

CQRM XD Compliance Risk Predictor

CQRM XD’s Compliance Risk Predictor helps Life Sciences companies conduct quantitative assessments of business risks. The patented 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, Compliance Builder 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.

Compliance Builder

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
  • Publishing
  • 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.

Ready to learn more? Book a free demo.