SMARTENOVAL

Your focus: validation of physico-chemical methods

SMARTENOVAL is software which helps generate reports for the qualification or validation of your analytical method both relative (LC, GC, EC, AAS,…) and absolute (titration, UV,…)

Benefits

Key values:

Always up-to-date and validated software, accessible from any location
Saves time with authority compliant report generation in just two minutes!
Simple, even for non-statisticians!
Best-in-class decision-making

Enables you to:

Assess the trueness, the precision and the accuracy of your analytical method and generate accuracy profiles to support the selection of the best calibration model
Evaluate the potential matrix effect in the calibration
Evaluate your risk in future routine analysis
Demonstrate that the method is able to provide accurate results in routine (reconstituted samples) but also on real samples (tablets)
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
Analysis of the matrix effect
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 and EDQM)
Decision-making tool: one graph = one decision
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:
- Linear Regression
- Weighted (1/X) Linear Regression
- Weighted (1/X²) Linear Regression
- Linear Regression Through 0. Fitted using the level of your choice
- Linear Regression Through 0. Using the Highest Level only
- Linear regression after square root transformation
- Linear regression after logarithmic transformation
- 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