SMARTSTABELITY

Benefits

Key values:

• Always up-to-date and validated software, accessible from any location 
• Saves time with authority compliant report generation in two minutes! 
• Simple, even for non-statisticians! 
• Best-in-class decision making 

Enables you to:

• Generate statistics in compliance with regulatory documents such as WHO, ICH Q1A, ICH Q1B, ICH Q1C, ICH Q1E, ICH Q6A, ICH Q6B, ICH Q5C, ICH Q5E and ICH M4Q
• Evaluate the long-term stability of your product and define its shelf-life
• Define the release limits
• Define the optimal experimental design to avoid testing all factor combinations
• Set up a standard re-test period for your product
• Identify out-of-trend results and batches
• Predict long-term stability based on accelerated studies

Our statisticians provide support for any questions concerning the use of the software and the processing of your data.

Features

• Use of Bracketing or Matrixing designs to define the total number of experiments and the relevant time-points, avoiding to test all combinations of stability factors
• Use of either fixed or random batch regression models to calculate the shelf-life, the release limits or a re-test period:
  • Simple linear regression
  • Quadratic regression
  • Linear regression after square root transformation
  • Linear regression after logarithmic transformation
  • Linear regression after inverse transformation
  • Non-linear mono-exponential decay
• Modeling of long-term shelf-life based on accelerated stability data with Arrhenius regression models
• Assessment of out-of-trend / out-of-specification batches to define a reliable shelf-life
• Generate an e-CTD compliant report within minutes, in full compliance with authority expectations, reporting in particularity one or two-sided confidence intervals for batch release limits, shelf-life and re-test period
• Suitable for GxP use: fully validated according to the GAMP5 guidelines and 21 CFR part 11 compliant
• Software as a Service (SaaS) application:
  • no installation required: no need to validate the system on site
  • no maintenance costs
  • can be accessed from any location
  • always the latest version available, free of charge