Caliber Metrix

Caliber Metrix (CaliberMetrix) is a digital quality metrics platform developed by Caliber Universal, purpose-built for pharmaceutical manufacturers seeking real-time, data-driven visibility into product and process quality. Sitting on top of existing data warehouses and quality management systems, CaliberMetrix consolidates all FDA-recommended quality metrics into a single interface, enabling one-click reporting, continuous compliance monitoring, and confident navigation of surprise FDA audits.

At its core, CaliberMetrix is powered by QUARI, Caliber Universal's analytics platform, which provides instantaneous access to real-time metrics and establishes a robust foundation for continuous data monitoring. By aggregating data from diverse sources and presenting it through intuitive visual analytics, the platform acts as a 'second brain' for quality teams — streamlining compliance reporting, supporting risk mitigation, and cultivating trust with regulators while significantly elevating product quality.

FDA-Recommended Quality Metrics Covered

• Corrective and Preventive Actions (CAPA): Verifies the effectiveness of CAPA actions, confirming that non-conformances have been resolved and recurrence prevented.
• Complaint Rate: Captures the voice of the patient and customer to track product-related complaints.
• Deviations Rate: Measures the effectiveness of the deviation management system.
• Environmental Monitoring (EM) Trends: Indicates the level of control and compliance of sterile aseptic sites with regulatory standards and guidelines.
• Incoming Material OOS: Highlights raw materials, packaging materials, or components that fail to meet specified quality standards during incoming inspection.
• Invalid OOS Rate: Reflects the robustness of laboratory operations by tracking invalid out-of-specification results.
• Valid OOS Rate: Investigates instances where a product or process fails to meet predefined specifications, ensuring root cause identification and corrective action implementation.
• Lot Acceptance Rate: Indicates the robustness of the commercial manufacturing process.
• Media Fill Failures: Reports on failed media fill units, root cause analyses, corrective/preventive actions taken, and repeat media fills conducted to demonstrate return to a state of control.
• PQR Reviews On Time: Confirms that periodic and timely quality reviews are consistently in place.
• Process Capability: Uses statistical measures such as Cp, Cpk, Pp, and Ppk to assess process performance and consistency, identifying opportunities to reduce variation or improve specifications.
• Recall Events: Provides essential insights into product safety and quality control incidents.
• Recurring Deviations Rate: Evaluates the effectiveness of the deviation management system and associated CAPA actions in preventing repeat issues.
• Right First Time: Tracks whether activities are performed correctly on the first attempt, eliminating the need for rework.
• Stability Failure Rate: Assures drug safety and efficacy by predicting the likelihood of product failure during shelf-life and assessing manufacturing process performance.

Key Platform Capabilities

• One-Click Access to Insights: Delivers standardized, real-time quality measures instantly, empowering pharmaceutical firms to quantify, analyze, and track critical product and process lifecycles with minimal effort.
• Real-Time Quality Metrics: Integrates all FDA-identified quality metrics into a single, easy-to-use interface by aggregating data from diverse sources, enabling real-time process monitoring and enhanced operational efficiency.
• Consolidated Metrics: Eliminates disjointed data and complex manual calculations by bringing all key quality metrics — including LOT acceptance rates, CAPA performance, Process Capability Analysis by product, and Deviation Rates — into one centralized location.
• Visual Analytics for Quick Action: Presents information in simple, easy-to-interpret visual formats, enabling rapid decision-making and quick responses to product and process changes. Comprehensive reports allow teams to monitor, track, and optimize quality metrics across business units.

Transition to a Risk-Based Approach

• Supports pharmaceutical manufacturers in moving from a time-based to a risk-based audit-readiness approach.
• Enables agile decision-making and continuous data monitoring to manage surprise FDA audits with confidence.
• Embeds high-quality processes at each step of manufacturing to ensure patient safety and satisfy strict regulatory requirements.
• Provides ongoing regulatory monitoring and real-time visibility into processes and quality statistics.

CaliberMetrix is designed to complement existing QMS and manufacturing solutions, operating as an analytics layer on top of your data infrastructure. It sets a new benchmark for Pharmaceutical Quality Systems (PQS) through its intuitive interface and robust analytics, making it a comprehensive tool for data-driven pharmaceutical manufacturing excellence.