Your focus: product stability and shelf-life estimation

SMARTSTABELITY is software dedicated to the evaluation of the long-term stability of your product and to the determination of its shelf-life.  


Value for you:

  • Standardize stability reporting across the organisation 
  • Always up-to-date and validated software, accessible from any location
  • Reduces report writing to a couple of minutes instead of days
  • Easy to use: made by statisticians for non-statisticians
  • Best-in-class decision making

Enables you to:

  • Evaluate the long-term stability of your product and define its shelf-life
  • Compute 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 degradation based on accelerated studies using the Arrhenius equation 

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


  • Generate an e-CTD report within minutes, in full 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 
  • 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 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

SMARTSTABELITY – the details

For a quick overview of how SMARTSTABELITY works, please check out our demo video >>

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