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