Execute the OQ

Execute the Operational Qualification to verify the correctness of mathematical calculations performed by PLA 3.0 at your workstation, using datasets verified by Stegmann Systems.

Note: The OQ process validates one PLA 3.0 installation at a time. If you work with several installations, you have to execute the process for each of them.

About this task

Each PLA 3.0 data analysis add-on comes equipped with protected operational reference data in the form of an Operational Qualification package (OQ package). An OQ package contains a set of verified datasets in the form of Operational Qualification documents (OQ documents).

When you execute an OQ, an OQ test document is created for each OQ document.

Generation of OQ test documents during the execution of an OQ
Figure 1. Generation of OQ test documents during the execution of an OQ

The OQ test document holds the verified dataset of the respective OQ document. It typically checks a single aspect of a complex calculation routine and contains descriptions of test purpose, data setup, and expected results. The OQ test document is calculated and the results are compared with the results from the verified dataset.

You can identify an OQ test document by a purple triangle in the upper right corner of the document icon .

Procedure

To execute the OQ:
  1. In the Navigator, select the folder where you want to save the OQ test documents.
  2. On the Validation menu, select Operational Qualification (OQ)….
  3. In the Operational Qualification (OQ) dialog, select the following data:
    1. Source file: The OQ package of the add-on you want to qualify.
    2. Report file: The directory where you want to save the OQ report. By default, the OQ process uses the default output path set in the PLA 3.0 preferences.
    Figure 2. Selection of the OQ setup for the Dose-response analysis package
  4. To start the OQ process, select Proceed.
  5. A dialog informs you about the progress and displays a corresponding message when the process is completed. To directly view the report, select OQ Report.
    Figure 3. Protocol details of a successfully executed OQ process
    Tip: To view details about the cryptographic signature applied to a specific protocol entry, select the entry and select Signature.

Result

The OQ report is saved in the directory you selected. If the execution was successful, the Certificate of Qualification is displayed on the first page of the report. If deviations are detected, the OQ fails and the report is generated without a certificate.

In the Navigator, an OQ folder is created for the validated add-on with subfolders for each document type. The OQ test documents of each document type are displayed in subfolders, mirroring the calculation routines they belong to.

This setup allows for easy extensibility of the OQ data. Additional calculation routines can be added without touching the original folder tree. Verification of OQ test documents within these folders remains valid.

Example

In the following example, an OQ was performed for the Dose-response analysis package version 1.0.0. For the Dose-response analysis document type, the test results for dose transformation are available in the 'OQ 03 Dose transformation' subfolder:

OQ results in the Navigator for the Dose-response analysis package
Figure 4. OQ results in the Navigator for the Dose-response analysis package
Tip: The Navigator displayed above uses a side-by-side view, comparable to Microsoft Windows File Explorer.