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 to quantify without the right tools in place to highlight the likelihood of being cited and the potential financial impact to 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 Risk Predictor can use the internal audit results to predict business risks.
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. Understanding higher visibility and prioritized actions make teams more productive and reduce costs.
Only Compliance Risk 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.
At the core of the Compliance Risk 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 resulting 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 Risk Predictor classifies all nonconformances based on a proprietary database and prioritizes actions based on the likelihood of citation and financial impact.
The RCMI score uses a 5-point scale that scorecards result 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.
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. Utilize the Predictive Compliance Report to make strategic plans and drive business decisions, and instantly access reports indicating where compliance violations exist.
The ability to reduce risk and noncompliance costs is at your fingertips. Compliance Risk Predictor leads your organization to prioritize your actions, create remediation plans, and automate monitoring resulting in better business outcomes.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.