Validating Your Chromatography System

The U.S. Food and Drug Administration defines validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes".¹ The essential components of the validation process are vendor qualification (VQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and a controlled, validated computer system.

Dionex offers a full range of validation services for the ICS, UltiMate, and Chromeleon product lines. Trained field service representatives are available to perform installation, operation, and performance qualification on your HPLC or IC system.

Performance validation kits are also available that contain all the tools, worksheets, methods, certificates, and validation tags necessary to validate individual system components.

Automating the Validation Process

Dionex data systems are designed to make all aspects of validation as easy as possible for the user. Validating the software installation is as simple as choosing a menu option and printing out the results.

To help automate the instrument validation process, OQ/PQ procedures and pass/fail criteria are built into the software. Validation "wizards" walk you through the creation of methods to validate your specific HPLC or IC configuration.

Whatever your laboratory's needs, Dionex has a validation solution that will make regulatory compliance easier. To request further information, contact technical support using the form found in the Contact Dionex section, or call 1-800-Dionex-0 between 6:00 am and 5:00 pm PST.

¹ General Principles of Validation; U.S. Food and Drug Administration. U.S. Government Printing Office: Washington, D.C., 1987.