Stay ahead of the curve and ensure audit readiness at all times. With a focus on safety, quality, and accuracy, embrace a platform that helps your transition to a risk-based approach and manage surprise FDA audits with confidence.
Ensure patient safety and satisfy strict regulatory requirements, it’s essential to embed high-quality processes at each step. Caliber Universal’s newest innovations, CaliberMetrix sits on the top of your data warehouse to generate one click quality metrics reports.
With Caliber’s Quality Metrics solution, manufacturers gain real-time access to critical data, enabling streamlined compliance reporting efforts and redirecting focus towards data analysis and risk mitigation. Our platform, QUARI, offers instantaneous access to real-time metrics, establishing a robust foundation for continuous data monitoring and reporting. This empowers agile decision-making and cultivates trust with the FDA, ultimately elevating product quality significantly.
No more scattered data or complicated calculations. CaliberMetrix simplifies your operations by bringing all critical quality metrics into one place.
The platform enables quick analysis and offers valuable insights into process performance.
Shows the number and identity of the media fill units that failed, the root cause analysis and corrective/preventive actions taken, the review of records and activities related to the aseptic process and the repeat media fill conducted to demonstrate the return to a state of control.
Indicates the level of performance and consistency of a process, using statistical measures such as Cp, Cpk, Pp, Ppk, which compares variation with the specification limits. The report helps to identify any opportunities for improvement, such reducing variation, centering the process, or widening the specifications.
Experience instant access to standardized quality measures in real time, boosting operational effectiveness and empowering pharmaceutical firms to quantify, analyze, and track critical product and process lifecycles, to make surprise audits seamless and comply easily.
Integrate all FDA-identified quality metrics into a single, easy-to-use interface. Through aggregating data from diverse sources, CaliberMetrix provides real-time insights into critical metrics, enabling real-time monitoring of processes and enhanced efficiency. It acts as a ‘second brain,’ to improve preventive actions, quality results and making audits effortless.
No more disjointed data or convoluted math. Streamline your business by consolidating all key quality metrics in one location. The system allows rapid analysis and provides insightful information regarding process performance. By consolidating metrics like LOT acceptance rates, CAPA performance, Process Capability Analysis (By Product), and Deviation Rates, etc.,
Information is delivered in a simple-to-interpret visual presentation. It can work on the top of your QMS and Manufacturing solutions, enabling you to make quick decisions and react quickly to product and process change. The system also produces comprehensive reports, so you easily monitor, track, and optimize quality metrics across units.
CaliberMetrix complements QUARI to offer timely quality metrics at your fingertips. Its intuitive interface and robust analytics feature the new benchmark for Pharmaceutical Quality Systems (PQS). With ongoing regulatory monitoring and the threat of surprise audits, companies need to have a trustworthy tool for real-time visibility into processes and reporting quality statistics.
Whether you’re monitoring compliance, enhancing processes, preventing risks, CaliberMetrix is your ultimate tool for data-driven pharmaceutical manufacturing excellence.
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