Validation, AutoQ, and System Wellness
AutoQ Equipment Qualification

Dionex AutoQ is a comprehensive range of user-friendly Chromeleon qualification tools. These tools help you quickly and easily perform qualification tasks that would otherwise be troublesome and time-consuming. In addition, they simplify compliance with qualification standards and qualification rules. AutoQ qualification tests are available for Chromeleon software and for several HPLC and IC systems. AutoQ test procedures can automate the following tasks.

For Chromeleon software:

• Installation Qualification (IQ)

• Operational Qualification (OQ)

For instruments:

• Installation Qualification (IQ)

• Operational Qualification (OQ)

• Performance Qualification (PQ)

What is unique about Dionex AutoQ?

Dionex AutoQ is a comprehensive suite of qualification procedures for instruments from several manufacturers. AutoQ is available for the following systems:

• Dionex IC modules, UltiMate 3000 and Summit HPLC modules

• Agilent 1100 and 1200 HPLC System modules

• Shimadzu LC10 and LC2010 HPLC instruments

• Shodex RI-101 HPLC Refraction Index Detector

• TSP HPLC modules

• Waters HPLC modules (including the Alliance 2690(D)/2695(D) Systems and the 996/2996 PDAs)

Which standards and regulations does Dionex AutoQ help you to meet?

The following standards and regulations are important in a validated environment:

• Good Laboratory Practice (GLP)

• Current Good Manufacturing Practice (cGMP)

• 21 CFR Part 11

• ISO 9000

What are the benefits of AutoQ?

• Most AutoQ tests run automatically most of the time. Therefore, they require very little operator time. For example, it only takes about 30 minutes to prepare the Instrument OQ, after which Chromeleon runs the test automatically. In comparison, the conventional test routines used in many validated laboratories typically require a full day of the analyst's time.

• The high level of automation reduces the risk of errors and ensures comparable results.

• Chromeleon automatically documents the results. The reports created by the system include charts, calculations, and the single results (Passed/Failed).

• AutoQ is virtually identical for all instruments, regardless of the manufacturer. This means:

- Considerable time savings for the creation and maintenance of SOPs (Standard Operating Procedures) for laboratories using instruments from different manufacturers.

- Only one test procedure to learn and work with.

- Test reports have the same format for all instruments.

- All reports can be easily managed, saved, and stored as electronic documents, using Chromeleon electronic reports and Electronic Signatures.

• AutoQ instrument qualification tests can be adapted for use with instruments from other manufacturers.

 Tip:

This requires advanced knowledge of report creation in Chromeleon.

• AutoQ qualification procedures are included in every Chromeleon software package.

 Note:

Certified standard solutions, which are available from Dionex, are needed to run AutoQ qualification tests.