Validation and Qualification
Documenting Chromeleon OQ

To document Chromeleon Operational Qualification, the Report (Printer Layout) CM_OQ.RDF contains the following sheets:

Regardless of whether the report is printed automatically or by selecting the Batch Report command, sheets 6 through 11 will be printed. All other sheets are only for calculation purposes, but can be printed as well.

Two different tests are performed:

a) The results of the parameter test are documented on the Report_Formula_Part1 sheet.

b) The results of the functions versus reference values test are documented on the sheets Report_CM_Part2 through Report_CM_Part5.

Test a): On the Current_Formula sheet (sheet 1), all parameters required for a Calibration Type are calculated (Calibration Type: Linear with Offset, Integration Type: Area, Standard Method (refer to Theory of Calibration  Standard Method in the User Help section): External, Calibration Mode: Total). Some calibration characteristics are calculated using the Report Publisher Functions. In addition, several SST parameters are evaluated.

The Current_CM_versus_Current_Formula sheet (sheet 5) compares the calibration characteristics (also see Calibration Coefficients) resulting from the calculations in Chromeleon to those resulting from the calculations with the documented formulas. TRUE is indicated if the values correspond to each other within the limits of the comparison formats described on the General_Information sheet (sheet 6). If the values do not correspond to each other, FALSE is indicated. The test is performed for each substance.

The results of the comparisons are transferred to the Report_Formula_Part1 sheet (sheet 7). On this sheet, TRUE is replaced by Ok and FALSE by Deviation. The entire test is evaluated as Passed if there is no deviation for any of the variables. If there is a deviation for at least one variable, the test is evaluated as Failed.

Test b): On the Current_CM sheet (sheet 2), the measured values are evaluated with the functions implemented in Chromeleon. The Reference_CM sheet (sheet 3) shows the numerical values that were calculated by the manufacturer during the validation of the respective version. On the Current_CM_versus_Reference_CM sheet (sheet 4), the newly evaluated parameters are compared to the values generated by the manufacturer. The comparison formats are described on the General_Information sheet (sheet 6). TRUE is indicated if both values correspond to each other within the limits of the comparison format. If the values do not correspond to each other, FALSE is indicated. The test is performed for each sample.

The different parameters appear on the sheets Report_CM_Part2 through Report_CM_Part5 (sheets 8 through 11). If the Current_CM_versus_Reference_CM sheet (sheet 4) indicates TRUE for all parameters of the associated Report_CM_PartX sheet (X = 2 through 5) for all samples, the corresponding report sheet is Ok. In all other cases, Deviation is indicated. The entire test is evaluated as Passed if there is no deviation for any of the variables. If there is a deviation for at least one variable, the test is evaluated as Failed.

The General_Information sheet (sheet 6) provides information about the version and the comparison format used for testing and indicates the names of the computer and the user.

For more information about Chromeleon Operational Qualification, refer to:

 Chromeleon Operational Qualification (OQ)

 Preconditions for Chromeleon OQ

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

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