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 1220USP 1225ISO 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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