Nova-Stability

Stability Study Management Software

The amount of time a product maintains its quality specifications is determined by an accurate, statistical shelf-life software that helps prevent potential negative impact to patients. Nova-Stability is a robust, process-based, feature-rich system that manages the entire stability testing process and is compliant with current regulatory guidelines on a global level.

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Nova-Stability | Stability Study Management Software

Trusted by Quality Teams Worldwide

30 years of global installations

Novatek has delivered regulated quality software since 1996.

Built for sterile and non-sterile manufacturing

Supporting aseptic operations, sterility assurance teams, and non-sterile manufacturers.

Implementation and validation support

Deployment, training, integrations, equipment interfacing, and validation documentation.

About the Software

Nova-Stability is a first-to-market, complete solution that accommodates all stability studies, including Accelerated, Long term, Intermediate, Stress testing on APIs, Transportation studies, Storage studies, Photo stability, and Forced degradation. It can be used for products in any phase, including commercial, pre-clinical/clinical, and post-approval commitment studies.

After 30+ years of collecting global client requirements, Novatek has perfected the industry’s most applicable stability statistical models:

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

Key Benefits

Statistics performed in seconds, eliminating the risk associated with manual calculations or the need for unvalidated software like Excel or JMP
Improved accuracy, reduced compliance risks, and significant time savings by having all stability data in a single system
Reduced risk of citations and human error with email notifications including escalation emails and sample barcode tracking
Avoid missed samples with Nova-Stability’s time point scheduling and sample pull reports

Key Features

Validated, built-in statistical package that addresses all statistical models

Ensures an automated and accurate shelf-life determination

Time point scheduling and sample pull reports

Ensure users are pulling the correct samples on time
Design a custom stability protocol with bracketing and matrixing, track your inventory “set down”
Easily view and report full sample pull history and chain of custody on all samples tested both internally and externally

Stability study submissions and reporting

Generate regulatory submission reports, study reports and user configured reports
Get access to all data at your fingertips
Data is highly available in real time from stability study protocol/registration reports, productivity reports, scheduling reports, data results report, investigation report to statistical reports, and more

Related Products

Nova-RM

Raw Material Analyzer Software

Nova-FP

In-Process & Finished Product Analyzer Software

Less work, faster results

Each Novatek software solution can be implemented as a standalone module or an integrated system complementing Nova-LIMS, your existing LIMS, or ERP/MES systems. Available interfaces to software and equipment and cloud deployment options available.

Ready to Get Started?

Don’t risk a costly repeat of your stability study. Contact Novatek today.

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