SMARTSEELVA

Your focus: validation of bioassays

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

Benefits

Key values:

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:

Assess 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

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

Features

Use of Total Error concept
Use of β-expectation Tolerance Interval to manage the risk in routine analysis, such as suggested in USP 1210
Generate an e-CTD compliant report within minutes, in full compliance with authority expectations (ICH Q2, FDA, ISO, EMA, MHLW, USP 1210, USP 1220, 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
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