Provide Evidence of Quality Under Various Conditions
Stability studies include complex processes to test how long a product can maintain its original quality specifications under normal use conditions, as well as the study of product-related factors that influence quality, such as interaction of the active pharmaceutical ingredient (API) with excipients, container-closure systems and packaging materials.
The burden of proof is on the manufacturer to prove all claims are accurate, which includes proving the validity of data and producing documentation in real-time to satisfy auditors.
With Labwise XD, labs can manage stability studies digitally, reducing mistakes that occur with manual paper-based processes. The Labwise XD stability module features quality, compliance and electronic lab notebook (ELN) functionality that creates a comprehensive solution for assuring compliance with regulatory guidelines globally.
With the Xybion Labwise XD Stability Module, you can maintain regulatory compliance and decrease your time to market.
With Labwise XD – Stability Management, you can:
Labwise XD handles all types of statistical models ensuring an accurate shelf-life evaluation, including:
- Regression Analysis
- Analysis of Variance (ANOVA tables)
- Analysis of Covariance (ANACOVA tables)
- Data Pooling (P-Value)
- Arrhenius Equations (regression and estimation models)
Stability Process Modules
- Create Study: Includes product, batch, storage conditions, and more
- Create Test Lists: Includes desired storage conditions and
- Starting Time: Specify a starting time for each storage condition
- Storage: Print labels and store samples
- Results: Enter results on lab work order (LWR) form(s)
- Work Order: Pull lab work order
- Calendar: Run calendar and request sample pulls
- Activate the Study
- Verify the Results
- Approve the Results
- Complete Study: Last LWR approved
- Report: Analyze and write stability report