Validation and Qualification
Chromeleon Operational Qualification (OQ)

The purpose of Instrument Operational Qualification is to prove that your instruments function according to their operating specifications. The purpose of Chromeleon Operational Qualification is to prove that the Chromeleon software behaves according to its specification in your specific working environment. The software regenerates data from special files and reevaluates them. The recalculated results are then compared to the reference data generated by the manufacturer.

To start Chromeleon operational qualification, select Chromeleon OQ on the Qualification menu in the Client. Chromeleon Operational Qualification runs almost automatically as a Wizard guides you through the process:

• Connect to the local Server PC.

• Load the CM_OQ.CFG server configuration file, which is required for Operational Qualification:

Dionex P680 LPG-4 pump (Demo Mode)

Dionex ASI-100 autosampler (demo mode)

Dionex UVD-340U PDA (demo mode: read)

Dionex TCC-100 Thermostatted Column Compartment

To check fractionation, the server configuration file also includes:

A Fraction Collection driver

Isco Foxy 200 Fraction Collector (demo mode)

In demo mode, it is possible to simulate all program commands that are available for the selected instruments. Besides, special files, from which new raw data is generated, are available for the UV detector. Based on the measuring parameters the data provided in the demo files is processed in the same way as the data acquired from a real sample.

• Template sequences are generated and copied based on the master sequence for Chromeleon OQ. The master sequence is provided on the Chromeleon CD.

• Chromeleon OQ is performed by processing the copied sequences, performing commands and properties of the four Dionex devices, the Fraction Collection driver, and the Isco Foxy Fraction Collector.

• The resulting raw data is evaluated using the CM_OQ.rdf report template. Two tests are performed:

The first test compares the parameters that are automatically calculated in Chromeleon with those that are calculated in the report using the documented formulas.

The second test compares the newly evaluated parameters to the reference values.

• If Operational Qualification was performed using the wizard, the wizard stops the server afterward and reloads the configuration used before Operational Qualification was started.

For more information, refer to:

 Preconditions for Chromeleon OQ

 Documenting Chromeleon OQ

For information about how to perform Chromeleon Operational Qualification, refer to How to: Working with Files, Databases, and Networks  Performing Chromeleon OQ.

For more information, refer to the Chromeleon Operational Qualification Operating Instructions.