NuGenesis Stability
Take control of your stability testing and increase workflow efficiency
Organizing stability testing regimes, managing long-term sample storage, and compiling and reviewing a product’s analytical results can be complex and demanding. Historically, integrated stability management and testing was largely only available to users of Laboratory Information Management Systems (LIMS) solutions.
Waters NuGenesis Stability module is a complete stability protocol management and testing solution integrated into your NuGenesis Laboratory Management System (LMS) designed to make robust stability management capabilities accessible to any organization. With NuGenesis Stability, your lab can gain workflow efficiency across research and manufacturing environments, enforce a consistent, compliant, and standardized stability operation, and minimize the risk of human error – all without a LIMS.
NuGenesis Stability
Overview
- Access a robust approach to stability testing previously only available to larger enterprises with a complex LIMS
- Enforce a consistent and standardized stability operation for maximum control while reducing the risk of human transcription or planning errors
- Facilitate the entire stability workflow and achieve efficiency improvements at every step
- Organize, track, and enhance analytical effectiveness with status and sample tracking and extensive statistical results analysis capabilities
- Comply with 21 CFR Part 11 guidelines using a fully validated and tested application with industry-recognized calculations
- Produce highly customizable eCTD compliant reports to streamline submissions
Recommended Use: For robust, compliant stability protocol management for use in research and manufacturing environments.
Features Header
Comprehensive stability management to meet today’s compliance requirements
Developed in accordance with current GAMP and ICH guidelines, NuGenesis Stability is a fully validated and tested software application that uses industry-recognized calculations. With NuGenesis Stability, your lab can operate under 21 CFR Part 11 compliance with a full set of capabilities, including:
- The definition of study matrices, including time points, storage conditions, and test regimes
- Management and control of the stability inventory.
- Sample pull overview across all active studies
- Individual time point reviews
- A suite of stability reports
- Extensive statistical results analysis
Make efficiency gains ongoing and easy
NuGenesis Stability delivers efficiency improvements at every step of the process with time-saving and error-reducing capabilities, so you can:
- Create streamlined stability protocols
- Accelerate the development of complex matrices with reusable templates
- Centralize inventory management, facilitate pull workload management, and record all storage transactions
- Simplify scheduling and support manual adjustments
- Easily calculate product shelf life based on statistical analysis
- Project expiry periods using single or pooled stability studies
- Support accelerated storage conditions (Arrhenius) calculations, trend analysis, and back calculation of purity
- Make decisions on the validity of pooling studies automatically
- Export files as graphic metafiles for easy insertion into Word documents
Reach a new level of testing operations standardization and harmonization
With NuGenesis Stability, your NuGenesis Lab Management System can enforce a consistent, standardized stability operations management workflow and regimen across all your operations – from product to product, laboratory to laboratory, and country to country. Small to mid-size businesses using less robust ways to manage their stability requirements can now access the efficiency advantages previously only available to larger enterprises with complex LIMS solutions.
NuGenesis Stability suits your laboratory software strategy – working as an integral part of the industry’s most comprehensive data management and workflow solution within the NuGenesis Lab Management System.
