SMARTENOVAL
Your focus: analytical method validation (physico-chemical)
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,…)
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 trueness, the precision and the Total Analytical Error (TAE) 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
- 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)
- 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 report within minutes, in full compliance with authority expectations (ICH Q2, FDA, 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
- 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 LOGARITHM transformation
- Linear Regression after SQUARE ROOT 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
SMARTENOVAL – the details
For a quick overview of how SMARTENOVAL works, please check out our demo video >>
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