NOVA-STABILITY Stability Management Software

NOVA-STABILITY Stability Management Software

Determining the shelf life of drugs is crucial for the long-term safety of patients, but managing stability studies is a complex and time-consuming process. This type of research typically lasts for three to five years, during which any errors may lead to product recalls and regulatory issues, even requiring the entire study to be redone, resulting in delayed product launch.

Regulatory agencies have extremely strict scrutiny of stability studies, and companies must demonstrate the validity of their data. To reduce the risk of research failure, it is necessary to use compliant software solutions to manage stability operations and conduct accurate shelf life analysis. Nowadays, complex and cumbersome spreadsheets are no longer suitable for data retrieval, review, and analysis. Implementing specialized stability software systems can avoid issues such as missed sampling, delayed sampling, non-compliance, and serious calculation errors.

NOVA-STABILITY Stability Management SoftwarePowerful features

Nova Stability is a standard solution in the industry, with over 20 years of application experience in hundreds of pharmaceutical and biotechnology companies worldwide. It can manage research projects ranging from single to thousands, covering the entire process from research and development to quality control. Nova Stability can handle production, preclinical/clinical, and post production commitment research with ease. This system can be used independently or integrated with your existing Nova LIMS, LIMS, or ERP/MES systems (such as SAP). Nova Stability provides paperless automated processes, saving time and reducing costs. It has built-in compliance requirements that comply with the latest ICH/FDA stability guidelines, 21 CFR Part 11, and data integrity guidelines, ensuring that your organization can reduce or eliminate all regulatory risks.

Complete sample tracking:

Missing samples is a regulatory risk that may force you to redo the entire study and delay product launch.

Reduce the risk of missing samples: Nova Stability's time point scheduling and sample extraction reports ensure that users always extract the correct samples on time.

Reduce non-compliance risks: automatic email notifications, including upgrade alert emails for missed samples.

Reduce the risk of human error: Use barcode functionality to track and scan samples, suitable for various operations including retrieval, retrieval, disposal, navigation, and searching throughout the Nova Stability application. By scanning the barcode, dozens of samples can be extracted at once.

Embedded statistical software package:

Manual or external statistical analysis may result in calculation errors and do not comply with 21 CFR Part 11 and FDA data integrity guidelines. These issues will make it difficult to validate and prove research results.

Reduce risks through industry validated embedded statistical software packages, with standard configurations including the following models:

regression analysis

Analysis of Variance (ANOVA Table)

Covariance Analysis (ANCOVA Table)

Data Pooling (p-value)

Arrhenius formula (regression and estimation model)

Inventory control:

Tracking inventory 'placement': marking and delineating stable inventory at the beginning of the study.

Complete sample extraction history: View the user's date and time for each extraction. Enable the events in your research to be clearly documented through the elements of who, what, where, when, and why.

Real time inventory in the sample room: Check the inventory in your sample room online at any time.

Sample Chain of Custody: Tracking extraction, transportation, receipt, disposal, and sample status.

Formula builder:

Use Nova Stability's powerful formula building tool to create and validate your own formulas in the system.

Reduce or eliminate the need to export results to external applications and maintain data integrity.