Pharmaceutical method validation

Validex

A web platform for analytical method validation in the pharmaceutical field: analysts enter their experimental data, and Validex runs the statistics, interprets the results and exports the report.

Platforms: Web

Workbench dashboard with a chromatogram run monitor, validation counts, report allowance and work in progress

Version results for a paracetamol HPLC assay, with configuration, traceability and conclusions per criterion

Overview

Analysts enter their experimental data for linearity, accuracy, precision and LOD/LOQ, and Validex runs the statistical tests set out in the SFSTP 1992 recommendations and ICH Q2(R2).

Each result comes with its interpretation, from Student tests on line intercepts and slopes to Cochran's variance homogeneity test, recovery confidence intervals and a clear verdict on whether each criterion complies. Work is organised by project, validation and version, with a traceable history of who created and submitted each version, and every version can be exported as a structured PDF report. The platform also tracks the calibration status of the lab's instruments, and works in both English and French.

Statistical engine
SFSTP 1992 and ICH Q2(R2) tests, interpreted
Traceable work
projects, validations and versions, exported to PDF
Lab instruments
calibration status for every instrument

Projects tree of validations and versions with their status and a details panel

Screens

9 screens, in context.

Next project

HealthSync

A healthcare platform that connects patients with trusted doctors and simplifies the appointment process.