Confidence Beyond Compliance

Your focus: validation of bioassays

Your objectives:

  • Assess the relative trueness, the precision and the accuracy of your bioassay (ELISA, RIA, parallel line, curve, slope-ratio and microbiological assays, qPCR,…) and generate accuracy and linearity profiles
  • Content module: generate reports for the qualification or validation of bioassays which provide results expressed in concentration or quantity
  • Potency module: generate reports for the qualification or validation of relative potencies assays for which analytical results are assumed following a lognormal distribution
  • Define the optimal experimental design

Introducing Seelva

  • Use of Total Error concept
  • Use of β-expectation Tolerance Interval to manage the risk in routine analysis
  • Generate an e-CTD compliant report within minutes, in full compliance with authority expectations (ICH Q2, FDA, ISO, EMA, MHLW, USP 1210, USP 1225, USP 1033 and EDQM)
  • 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
  • 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
  • Our statisticians provide a support (hotline) for any questions concerning the use of the software and the processing of your data
  • 10 different statistical models proposed, 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