SOSstat VPAQ

What is SOSstat VPAQ?

Introduction to SOSstat VPAQ

In chemical, pharmaceutical and food processing, analytical methods are used to verify the quality of products. The validation of these procedures, in line with the commitment to regulatory and quality requirements, allows manufacturers to guarantee the quality of their products.

Currently, many methods have been proposed, mainly based on statistical criteria, are usually complex, expensive and difficult to interpret. SOSstat VPAQ implements a validation technique provided by SFSTP and NF V 03-110. This analytical method, based on the calculation of the total error, has the particularity of being simple to interpret, precise and relevant. This validation protocol has shown through numerous applications, its "universal" character. In addition, it has the advantage of meeting the requirements of the ICH and proposes metrological definitions according to ISO 5725.

The accuracy profile is applicable both to internal validation in laboratory tests and to the interpretation of data collected in the context of interlaboratory study, according to the guidelines of ISO 5725-2. The proposed approach should allow for internal validation methods in the following areas:

Non-standard methods

Methods developed by the laboratory

Standard methods used outside the intended scope

modifications of standard methods

an alternative method compared to a reference method

SOSstat VPAQ Features

With a dynamic graphical interface, SOSstat VPAQ simplifies the implementation of the validation protocol. The design of the software allows you to follow step by step the method roadmap. GUI elements are resizable to better fit all hardware environments. Numerous graphs provide an efficient analysis and interpretation of the results.

Validation according to the accuracy profile method (or total error method)

Prevalidation of analytical methods by the total error method

Ability to handle asymmetric matrix of the design

Setting up and saving analytics

Copy and paste data to/from worksheets

GUI resizable according to screen resolution

High-quality, dynamically updated graphics

Export graphics as: eps, emf, png, pdf, svg

Export a report in PDF format, with optional integration of definition and validation data. PDF report can be password protected to protect data

Write a custom report in VPAQ and print or export to a word processor

Results of the analyses

Response function model (9 models can be installed)

Calculation of the correction to be applied to the measures

Quantification of the matrix effect

Bias, relative bias, recovery

Repeatability, Intermediate Accuracy, Relative Standard Deviation

Accuracy, total error

Tolerance interval in total error

Limits of quantification of the method

Calculation of performance indices to select the best response function

Calculation of limits of quantification

Graphics

All charts can be changed dynamically (zoom, scroll) for easy interpretation and analysis. In addition, it can be saved in image or vector formats in a quality suitable for scientific publications.

Calibration response function

Calibration linearity

Absolute precision and relative precision

Total error profile

Risk profile

Precision profile

Linearity of measurement

Data integrity

SOSstat VPAQ implements security mechanisms to ensure data integrity.

A log file records user access to different files

Files are signed to detect any attempt to spoof data

Data files can be encrypted with password protection

System Requirements

32-bit and 64-bit Windows platforms.