Novatek International

Novatek International

- Stability Management Program

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Determining of the shelf-life of a pharmaceutical product is critical for understanding how long that product can maintain original quality specifications. Product used after the expiration date can negatively impact a patient. For this reason the shelf-life determination must be accurate.

The stability studies required to evaluate shelf-life can take several years to complete. Mistakes made during this process can result in repeating an entire study resulting in long delays getting the product to market.

Managing a stability study is a complex process and mistakes can occur. Using a manual paper based system increases the risk of errors. The only solution is to implement a software based process that automates your stability studies and shelf-life analysis. Stability studies are highly scrutinized by regulatory agencies. Companies must be able to prove the validity of their data. Automated solutions provide the ability to produce the necessary documentation in real-time to satisfy auditors. Systems like Nova-Stability helps companies maintain regulatory compliance while reducing risk to the patient.

Nova-Stability is a powerful process based feature-rich system that manages the entire stability testing process. This comprehensive solution is compliant with current regulatory guidelines on a global level.

Nova- Stability accommodates all types of 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 post production commitments studies.

Nova-Stability performs the follow stability studies:

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

Nova – Stability Management has a built in statistical package that handles all types of statistical models ensuring an accurate shelf-life evaluation. All calculations can be performed in minutes, eliminating the risk associated with manual calculations or the need for separate software like Excel. Having all calculations in a single system improves efficiency, reduces risk and provides a significant time savings.

Nova-Stability utilizes the following statistical models:

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

These validated statistical 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.

Nova-Stability software can be provided as a standalone module or as an integrated system complementing Novatek-LIMS, your existing LIMS or ERP/MES systems such as SAP.

Using the Nova-Stability system can reduce the risk to your patients and bottom line. Get an accurate determination of the shelf-life, maintain regulatory compliance decrease your time to market with Nova-Stability!

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