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