Compliance Predictor Overview

Life Sciences industries are among the most heavily regulated in the world with companies today facing an increasing number of disputes and regulatory, compliance, and investigation issues. The risks of noncompliance include severe financial penalties, delayed product launches, and reputational risks that can cause damage to the organization. Organizational silos and interdependencies with third party partners make understanding vulnerabilities even more daunting.

Compliance officers have the onerous task of implementing safeguards, monitoring compliance, and predicting and reporting on business risks. Understanding where an organization’s highest exposure risk area can be difficult without the right tools in place to quantify the likelihood of being cited and the financial impact the exposure has on the organization. All too often compliance scores are qualitative rather than data-driven.

Xybion Predictive Compliance solution helps with planning, executing and reporting internal audits. This helps in standardizing audit processes, and audit checklists. Compliance PredictorTM can use the internal audit results to predict business risks.

Do you know your quality score?

Compliance 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. Understanding higher visibility and prioritized actions make teams more productive and reduce costs.

Only Compliance Predictor provides a quantitative score for a company’s Risk & Compliance Maturity Index (RCMI) at the company level, country level and functional area level, and turns it into actionable information that empowers you to prioritize actions based on findings. The tool can be used internally as well as with your third party vendors.

How it works

At the core of the Compliance Predictor solution is a proprietary industry index that compiles 483 citation documents, internal audit databases, Department of Justice fines and settlements, and a country business risk database. The data lake includes more than 35,000 records from the past ten years and continuously pulls in the latest information to make real-time reporting and trend analyses possible.

To determine your company’s RCMI, the system identifies the regulatory compliance risk and guides users through a questionnaire that assesses your current state of maturity. Follow-up audits are conducted based on identified areas of risk. During the audit stage, the system automatically finds nonconformances in documents. Compliance Predictor classifies all nonconformances based on a proprietary database and prioritizes actions based on the likelihood of citation and financial impact.

Know your score

The RCMI score uses a 5-point scale that scorecards results by functional area and location so that you can easily identify aggregate and function- or location-specific results. The ability to drill down into the report allows you to prioritize areas of focus.

Sample scorecard:

You can further drill into functional reports. The system provides reports of risk areas based on function vs. control types. The Predictive Risk Algorithm assesses audit results against risk based on external and internal data sources.

Sample report:

Actionable information

The ability to reduce risk and noncompliance costs is at your fingertips. Compliance Predictor helps you to prioritize your actions, create remediation plans, and automate monitoring. Contact Xybion to learn more.