NOVA-STABILITY

NOVA-STABILITY is a powerful, process-based stability management system developed by Novatek International, designed to manage the entire stability testing process from start to finish. Built for pharmaceutical and life sciences organisations, it addresses the critical need for accurate shelf-life determination — ensuring that products maintain their original quality specifications throughout their intended lifespan. The system is compliant with current regulatory guidelines on a global level, making it suitable for companies operating across multiple regulatory jurisdictions.

Managing stability studies manually introduces significant risk of error, and mistakes can result in repeating entire studies, causing costly delays in getting products to market. NOVA-STABILITY replaces paper-based processes with an automated, software-driven workflow that reduces risk, supports regulatory compliance, and provides real-time documentation to satisfy auditors. The system accommodates products in any phase, including production, pre-clinical and clinical stages, and post-production commitment studies, and supports formulation development, bracketing, and matrixing within a study.

Types of Stability Studies Supported

• Accelerated stability studies
• Long-term stability studies
• Intermediate stability studies
• Stress testing on active pharmaceutical ingredients (APIs)
• Photostability studies

Built-In Statistical Capabilities

• Regression analysis
• Analysis of variance (ANOVA tables)
• Analysis of covariance (ANACOVA tables)
• Data pooling (p-value)
• Arrhenius equations (regression and estimation models)

Key Benefits and Features

• Comprehensive end-to-end management of all stability study types within a single system
• Built-in validated statistical package that eliminates the need for separate tools such as Excel
• All statistical calculations can be completed in minutes, significantly reducing time and manual calculation risk
• Graphical reports combined with validated statistical tools provide real-time data and visuals for complete study control and informed decision-making
• Supports accurate shelf-life determination to protect patient safety and reduce regulatory risk
• Enables real-time generation of documentation required for regulatory audits
• Reduces time to market by streamlining the stability study management process

NOVA-STABILITY can be deployed as a standalone module or as an integrated solution complementing Novatek's own Nova-LIMS, an existing LIMS, or ERP and MES systems such as SAP, providing flexibility to fit within an organisation's existing technology infrastructure.