Novatek’s Stability Management Program is a powerful feature-rich system that facilitates start to end management of all types of Stability Studies, from study design to sample storage, to analytical testing, approval phases and most importantly statistical analysis, shelf life determination and reporting. Novatek stability management is a comprehensive solution designed in accordance with current regulatory requirements such as 21 CFR Part 11, Annex 11, ICH and other international stability guidelines.  Novatek Stability software is provided as a standalone module or as an integrated system complementing Novatek-LIMS, your existing LIMS or ERP/MES systems such as SAP.

Stability System Features:

• Stability Study design
• Inventory requirement calculations
• Inventory management (from set down to discard)
• Storage condition/location monitoring
• Time point scheduling and sample pulling management
• Testing workload management
• Lab resource management
• Sample chain of custody
• Automated or manual result entry
• Data review and approvals
• Built in stability statistical package (Arrhenius, P-value, pooling of data)
• Built in Shelf-life and trend analysis
• Built in stability FDA compliant reporting package and report manager

Stability Study Control:
Novatek’s Stability Management Program accommodates any type of study including accelerated, long term, forced degradation, and photo-stability studies. It also provides for formulation development, bracketing and matrixing within the study and can be used for products in any phase including production, pre-clinical/clinical as well as marketed products.

The cornerstone advantage is the built in report manager and statistical analysis component that allows the user to produce the essential reports and trend to effectively assess product stability and shelf life determination.  Features which include regression analysis, statistical modeling (ANOVA and ANACOVA tables), data pooling (p-value), and the Arrhenius equation are at your fingertips in just a few clicks. These validated tools, combined with the program’s graphical reports empower users with real-time data and visuals for complete study control and informed decision making abilities.

Legacy and manual systems used to handle stability operations are outdated and non-compliant with the latest regulatory requirements.  The time consuming task of creating schedules is an risk prone, error ridden and tedious process.  Manual reporting and shelf life analysis requires hours or even days to complete. Large operational risks are inherent when trends are manually created, exported to or copied from non-compliant systems. Whether you are a traditional pharmaceutical company, biotech company, contract research organization or contract manufacturer, automating your stability operations with the  latest and most reliable global solution is the best way to improve regulatory compliance, lower risk, expedite internal processes and improve your organization’s bottom line.

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