Confidence Beyond Compliance

Your focus: validation of physico-chemical methods

Your objectives:

  • Generate reports for the qualification or validation of your analytical method both relative (LC, GC, EC, AAS,…) and absolute (titration, UV,…)
  • 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 perform accurate results in routine (reconstituted samples) but also on real samples (tablets)
  • Define the optimal experimental design

Introducing Enoval

  • Use of Total Error concept
  • Analysis of the matrix effect
  • Use of β-expectation Tolerance Interval to manage the risk in routine analysis
  • Generate an e-CTD compliant report within minutes, in full compliance with authority expectations (ICH Q2, FDA, ISO, EMA, MHLW, USP 1210, 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
  • 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
  • Our statisticians provide a support (hotline) for any questions concerning the use of the software and the processing of your data
    • 10 different statistical models proposed, 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 X only
    • 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