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,…)


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


  • 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

Streamlining analytical method validation with SmartSTATS\Enoval across the organization

Spending vast amounts of time and resources on validation of analytical methods? With SmartSTATS, writing a validation report should not take more than a few minutes! Our SmartSTATS\Enoval is used by major pharmaceutical companies to simplify and streamline the method validation process across the organisation while meeting the highest industry standards.

SMARTENOVAL – the details

For a quick overview of how SMARTENOVAL works, please check out our demo video >>

Contact Us

Contact Form

Complete this form to stay in contact with us.

Global Approach

PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.

Scroll to Top