CaliberMetrix

CaliberMetrix offers a comprehensive solution for managing FDA-recommended quality metrics in the pharmaceutical industry. It facilitates a transition from a time-based to a risk-based audit-ready approach, ensuring continuous audit readiness with a focus on safety, quality, and accuracy. This platform aids in managing surprise FDA audits confidently.

By embedding high-quality processes at every step, CaliberMetrix ensures patient safety and compliance with stringent regulatory requirements. It sits atop your data warehouse to generate quality metrics reports with a single click. The platform provides real-time access to critical data, streamlining compliance reporting and allowing manufacturers to focus on data analysis and risk mitigation. QUARI, the platform's core, offers instantaneous access to real-time metrics, fostering agile decision-making and building trust with the FDA, ultimately enhancing product quality.

CaliberMetrix consolidates all critical quality metrics into one platform, eliminating scattered data and complex calculations. It enables quick analysis and valuable insights into process performance. Key features include:

• Corrective and Prevention Actions (CAPA): Verifies the effectiveness of CAPA actions, ensuring non-conformance issues are resolved and prevented from recurring.
• Complaint Rate: Represents the voice of patients and customers.
• Deviations Rate: Assesses the effectiveness of the deviation management system.
• EM Trends: Monitors control and compliance of sterile aseptic sites with regulatory standards.
• Incoming Material OOS: Reports on raw materials failing to meet quality standards during inspection.
• Invalid OOS Rate Report: Indicates the robustness of laboratory operations.
• Valid OOS Rate Report: Investigates failures to meet specifications, ensuring root causes are identified and addressed.
• Lot Acceptance Rate: Reflects the robustness of the commercial manufacturing process.
• Media Fill Failures: Details failures in media fill units and corrective actions taken.
• PQR Reviews On Time: Ensures timely quality reviews are conducted.
• Process Capability: Evaluates process performance and consistency using statistical measures.
• Recall Events: Provides insights into product safety and quality control.
• Recurring Deviations Rate: Measures the effectiveness of deviation management and CAPA implementation.
• Right First Time: Ensures activities are performed correctly initially, reducing rework.
• Stability Failure Rate: Predicts drug product failure likelihood during shelf-life and assesses manufacturing process performance.

CaliberMetrix enhances the pharma value chain by providing one-click access to insights, integrating all FDA-identified quality metrics into a single interface. It aggregates data from diverse sources, offering real-time insights and monitoring for enhanced efficiency. The platform acts as a 'second brain,' improving preventive actions and quality results, making audits effortless.

With consolidated metrics, the system streamlines operations by centralizing key quality metrics, allowing rapid analysis and insightful information on process performance. Visual analytics deliver information in an easy-to-interpret format, enabling quick decision-making and rapid response to changes. Comprehensive reports facilitate monitoring, tracking, and optimizing quality metrics across units.