Quality, Compliance, Risk & Content Management

The Life Sciences industry is 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.

Xybion offers a cloud-based, integrated, multi-module software platform that addresses all aspects of governance, risk, quality, compliance, enterprise and operational risks, accreditation, and third party audit and risk management. These modular components are detailed below:

Xybion’s eQCM-XD™ is a highly-adaptable and technologically-advanced Governance, Risk, Compliance (GRC) & Quality Management System (QMS) designed for today’s digital world. Purpose-built with embedded quality and compliance, this next-generation platform ensures compliance, risk and quality in complex and highly-regulated industries.

eQCM-XD provides powerful cloud-based capabilities that facilitate organizational compliance with regulatory guidelines such as ISO 9001, ISO 13485, ISO 17025, ISO14001, GxP, 21 CFR Part 11, financial reporting and governance regulations (SOX, CA Bill 198), and other risk-based regulations and industry standards.

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ComplianceBuilder™ 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.

To enable data integrity, it enhances the security of the applications to a new level through a security wrapper that can be placed around the application and file storage area, monitoring data changes such as data creation, deletion or modification. ComplianceBuilder offers complete flexibility in establishing your managed folder criteria by specific directory, workstation, file type, or file server.

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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 making teams more productive and reduces costs.

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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.

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