Validation and Qualification

Analysis data from various workstations or laboratories can be compared only if it is possible to determine the quality of the results produced with a chromatography system. This is why Validation and Qualification have become increasingly important for modern laboratories.

When is qualification necessary?

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.

In addition, the data system itself 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 (= datasource Performance Qualification (PQ)). Performing the different qualifications is usually the task of the system administrator. For more information, refer to the Administrator Help section:

 Validation and Qualification

 Performing Chromeleon OQ.

Many instruments perform an automatic self-test upon startup to ensure optimum function. For example, for the Dionex UVD 340U Photodiode Array Detector, spectra calibration is performed automatically via the Holmium Oxide Filter whenever the detector is started.

When is validation necessary?

The analytical method and the PGM File should be validated before they are used in daily laboratory procedures. As modifying single parameters can already be of great importance, validation is also necessary in the daily routine. On the SST tab page of the QNT Editor (see Data Representation and Reprocessing  The QNT Editor), define System Suitability Tests to check whether your analytical method and your program file are suitable for analyzing special samples.

How is validation performed?

The focus of an analysis procedure is on Calibration (see Theory of Calibration  Calibration (Overview)). Within the scope of validation, it is then important to check whether calibration has been performed correctly. The precision, Limit of Detection, dynamic work range, and robustness of a procedure and the involved components have to be determined. The following features are available for this: Validation Samples, Blank Run Samples, Matrix Blank Samples, Confidence Interval/Range, averaging, normal distribution, outlier tests, detection of statistical and systematic errors, Correlation Coefficient, Standard Deviation, Relative Standard Deviation, etc.

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

 AutoQ Equipment Qualification

 The System Suitability Test (SST)

 System Wellness for IC Devices (Overview)

 System Wellness for Summit HPLC Devices

 System Wellness and Predictive Performance for UltiMate 3000 Devices (Overview)