SMARTSEELVA

Your focus: bioassay validation

SMARTSEELVA is software that validates bioassays such as ELISA, RIA, parallel line, parallel curve, slope-ratio, microbiological assays, qPCR and many more.

Features

Value for you:

  • Standardize validation 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:

  • Compute the relative trueness, the precision and the Total Analytical Error (TAE) of your bioassay  
  • Content module: generate reports for the qualification or validation of bioassays in line with ICH Q2
  • Potency module: generate reports for the qualification or validation of relative potencies assays for which analytical results are assumed following a lognormal distribution, in compliance with USP 1033
  • Define the optimal experimental design
  • Can be used for method optimization within QbD framework

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

Benefits

  • Use of Total Analytical Error (TAE) concept (i.e. combine bias and precision
  • Use of β-expectation Tolerance Interval to manage the risk in routine analysis, such as suggested in USP 1210
  • Generate an e-CTD report within minutes, in full compliance with authority expectations (ICH Q2, FDA, ISO, EMA, MHLW, USP 1210, USP 1220, USP 1225, ISO 17025, ISO 15189 and EDQM)
  • In compliance with ICH Q2(R2) (second revision) draft from 22-MAR-2022
  • Decision-making tool: one graph = one decision
  • Flexible variance component analysis (up to 5 factors)
  • Assessment of the format of the reportable value
  • Suitable for GxP use: fully validated according to the GAMP5 guidelines and 21 CFR part 11 compliant
  • 10 different statistical models proposed for calibration, easy selection thanks to the Accuracy Index:
    • Four Parameter Logistic Regression
    • Weighted (POM) Four Parameter Logistic Regression
    • Five Parameter Logistic Regression
    • Weighted (POM) Five Parameter Logistic Regression
    • Log-Log Regression
    • Power Regression
    • Weighted (POM) Power Regression
    • Quadratic Regression
    • Weighted (1/X) Quadratic Regression
    • Weighted (1/X2) Quadratic Regression
  • 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

SMARTSEELVA – the details

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

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