SMARTSEELVA

Benefits

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
• Simple, even for non-statisticians!
• Best-in-class decision making

Enables you to:

• Compute the relative trueness, the precision and the accuracy of your bioassay (ELISA, RIA, parallel line, curve, slope-ratio, microbiological assays, qPCR and many more) 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
• 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.

Features

• 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