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Xybion Wins the Best of Show Award at Bio-IT World 2024

Xybion ai, an innovative ML-powered Generative AI solution, recently won the People’s Choice Best of Show Award at the 2024 Bio-IT World. After receiving a patent on a business algorithm to predict risks, the approach of Compliance Risk Predictor in predicting and mitigating compliance risks stands out as a truly exceptional innovation in life sciences technology. This innovative software addresses a critical need in the life sciences industry by predicting potential compliance risks and helping organizations avoid costly FDA 483s. Compliance Risk Predictor monitors documents in real-time and predicts non-conformance issues before professionals flag them. This helps organizations be always compliant and audit-ready.

Our innovative Compliance Risk Predictor solution garnered the Best of Show Award, solidifying our position as a leading innovator in life sciences technology.

With the success of risk prediction, Xybion is now invested in predicting quality and other operational parameters beyond compliance. This includes expanding predictive analytics to optimize manufacturing processes and ensuring product quality by anticipating defects and non-conformances before they occur. This enhances overall operational efficiency and quality and results in predictable outcomes. Xybion’s innovative approach now aims to incorporate machine learning algorithms to monitor laboratory conditions, predict equipment failures, and optimize supply chain management. By extending our predictive capabilities beyond compliance, Xybion is setting a new standard in the proactive management of quality and compliance, thereby reducing costs, and improving productivity across life sciences organizations.

Xybion ai solution includes the automation of batch manufacturing record reviews, a process traditionally consuming substantial time and effort. By automating the review, Xybion significantly accelerates the batch release process resulting significant reduction of in-process manufacturing inventory and release products faster.

Another area of focus is document quality review. As per FDA citations report, over 30% of FDA citations are related to documentation issues. Xybion ai offers real-time monitoring and prediction of non-conformance in documents. This automation ensures continuous audit readiness by streamlining the review of hundreds of SOPs, work instructions, policy documents, training records, and project documents to maintain GxP compliance. Reducing errors during the early stage of creation helps reduce the delivery time and significantly reduces the cost of quality.

Additionally, the daunting task of third-party audit and risk management is transformed by Xybion ai, which standardizes, digitizes, and automates supplier audits. Most companies and regulators carry a large audit backlog that can be worked on easily using Xybion ai. This comprehensive approach enables companies to:

· Reduce the number of FDA citations and non-conformances by proactively identifying and addressing issues.

· Enhance the overall quality of outputs.

· Ensure a more compliant supplier network.

· Drastically cut down audit time.

By employing these advanced capabilities, life science organizations, regulatory agencies, academia, and all other related industries can always be prepared for regulatory audits, with the predicted outcomes known well in advance to ensure nonconformances are addressed proactively. We estimate that these organizations can improve their compliance productivity by about 60% across the value chain.

Xybion’s Compliance Risk Predictor leverages advanced machine learning algorithms to analyze vast amounts of data from various sources, including historical quality events, audit findings, and regulatory actions. By identifying patterns and trends, the software can proactively alert companies to potential compliance risks, enabling them to take corrective actions before issues escalate.

Xybion’s award-winning AI seamlessly complements our industry-leading quality management system (QMS), Xybion QMS. In a recent report, “Market Guide to GRC Tools for Assurance Leaders,” Gartner, a renowned research and advisory firm, highlighted Xybion QMS as one of the representative vendors in the GRC (Governance, Risk, and Compliance) tools market. The report provides an in-depth analysis of the GRC tools landscape, helping assurance leaders evaluate and select the most suitable solutions for their organizations.

Xybion QMS differentiates itself through the enhancement of quality management processes that meet the core capabilities identified by Gartner for effective GRC management. These include risk governance, risk analysis, risk monitoring, risk response, and risk reporting. As a powerful cloud-based solution, Xybion QMS supports organizations in adhering to regulatory standards, such as ISO, GxP, 21 CFR Part 11, and various governance and financial reporting regulations. The system’s extensive features include document management, training management, CAPA (Corrective and Preventive Action), and audit management, all integrated into a single, intuitive platform.

As organizations continue to face increasingly complex risk profiles, the demand for robust GRC tools is rising. Gartner predicts that by 2026, legal and compliance department investments in GRC tools will increase by 50%. Xybion QMS, with its unique, comprehensive capabilities and industry-specific expertise, helps assurance leaders meet these challenges head-on. By recognizing Xybion QMS as a representative vendor in the GRC Tools for Assurance Leaders market, Gartner acknowledges the system’s ability to meet the core functionalities and support assurance leaders in managing governance, risk, and compliance within their organizations.