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E-noval is a software dedicated to the validation of physico-chemical method both relative (LC, GC, EC, AAS,...) and absolute (titration, UV,...).

E-noval allows you to assess the trueness, the precision and the accuracy of your analytical method. In addition, it helps to evaluate a potential matrix effect in the calibration. E-noval generates Accuracy Profiles that are the keys to take a decision about the way for calibrating (which regression model, within or without matrix) and about the validity of your method.

  • E-noval is the validation software for your laboratory that guarantees that your methods will be compliant to regulatory documents such as ICH, FDA and ISO.

  • E-noval is a statistical software using SAS for the computation of your data

  • E-noval will also generate a stand-alone report. In a couple of minutes you get the final report of your validation

  • E-noval is based on the Total Error approach.

  • E-noval is a decision tool: one graph = one decision.

  • E-noval makes the statistic easy to understand and to interpret; Accuracy Profile is summarising all the information you need to know.

  • E-noval proposes you 10 statistical models to compute your calibration data. A ranking will be proposed to help you in the decision (Accuracy Index)

  • E-noval gives you the possibility to analyse the matrix effect for the calibration. You will introduce 2 set of data (without matrix, within matrix) for the calibration, and the software will propose you the accuracy profile using the best calibration model (within or without matrix) based on the more accurate back-calculated results.

  • E-noval will help you to manage your RISK. Through the β-expectation Tolerance Interval, you simulate how your method will behave in routine.

  • E-noval is an Internet based application on a secured website (https://). No installation and maintenance cost. Always the latest version available.

Calibration Models available:

Linear regression through 0 using the highest level
Linear regression through 0 using a specified level
Linear regression
Weighted (1/X) linear regression
Weighted (1/X²) linear regression
Linear regression after (base 10) LOGARITHM transformation of both concentration and response
Linear regression after SQUARE ROOT transformation of both concentration and response
Quadratic regression
Weighted (1/X) Quadratic Regression
Weighted (1/X²) Quadratic Regression

 

How will you benefit from e-noval ?

  1. e-noval meet ICH, FDA, Washington Conference and ISO requirements in Validation of Analytical methods
  2. e-noval adequately analyze the data of the validation phase of your analytical methods to ensure perfect conformity to requirements such as for example linearity, precision, trueness, accuracy, limits of quantitation and detection, quality of fit, residuals,...
  3. e-noval have been developed and validated in strict accordance with requirement in software validation such as 21CFRpart11, GxP, ISO.
  4. e-noval  is not only a statistical tool but also a report generator. In 20 minutes, you will have not only the statistical calculation of your data but also a fully stand alone pdf report which will contain all the information you have to report for the validation of your method.
  5. Computations and delivery are performed using SAS 9.1 system, the definitive reference of quality in number processing.
  6. Risk Management: through β-expectation Tolerance interval, you are able to predict the results your method will produce in routine analysis.

 

Screenshots & Technical sheets of e-noval: English - Français - Chinese

If you want to try it for 1 month, just fill the application form

 

 

 

 

 

Extracts of pages from the report generated by e-noval
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