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
To find out more or request a demonstration
SMARTSEELVA – the details
For a quick overview of how SMARTSEELVA works, please check out our demo video >>