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