Validation and Qualification

Analysis data from various workstations or laboratories can only be compared if it is possible to determine the quality of the results produced with a chromatography system.

Validation (Definition)

The process of ensuring that a system supplies reproducible and reliable results is referred to as validation. This includes above all procedures regarding the planning, implementation, and documentation of an analytical method. Thus, validation is an integral part of GLP ("Good Laboratory Practice").

Qualification (Definition)

First, the manufacturer validates the single devices and the data system. During qualification, the user checks whether a device or data system works according to its specification. This includes procedures guaranteeing the optimum technical condition of instruments (hardware and firmware) and of computers (hardware and software). Thus, qualification, too, is an integral part of Good Laboratory Practice.

When is qualification necessary?

Chromeleon should be qualified at least after an update. Installation Qualification and Operational Qualification are available for this. In addition, you can check the datasource performance (see Performance Qualification).

Instruments should be qualified before setting them into operation and at regular intervals thereafter; especially after exchanging worn-out parts, performing repair work, or replacing an instrument by a new one. Also, perform system qualification procedures after you have updated the software of your data system.

Chromeleon provides numerous options to meet all GLP, qualification, and validation requirements. For more information, refer to:

 Chromeleon Installation Qualification

 The CmSetup.log Log File

 Chromeleon Operational Qualification (OQ)

 Instruments Installation Qualification

 Datasource Performance Qualification (PQ)