Operational Qualification

The Operational Qualification process (OQ process) of the PLA 3.0 Validation Package verifies the correctness of mathematical calculations performed by PLA 3.0 on the target system, using datasets verified by Stegmann Systems.

OQ process

The OQ process uses the protected operational reference data delivered with the PLA 3.0 installation and compares it with the calculation results obtained by PLA 3.0 in the target environment.

PLA 3.0 OQ process in the target environment
Figure 1. PLA 3.0 OQ process in the target environment
Note: The OQ process of the PLA 3.0 Validation Package does not cover user interface tests such as password and audit trail tests.

When activating a data analysis add-on in the PLA 3.0 database, the respective OQ package is automatically made available.

To start the OQ process, customers select the OQ package of the add-on they want to validate. The OQ process decrypts the OQ package and verifies the XML signatures and checksums of the included OQ documents. If verification is successful, PLA 3.0 processes the OQ documents and compares the calculation results.

Tip: Customers who want to revalidate the calculation results obtained by PLA 3.0 can use the OQ test document data to set up mathematical calculations in other software programs and cross-check the results.

Dataset verification

Stegmann Systems verifies datasets by comparing the calculation results of PLA 3.0 with results from other software products such as Wolfram Mathematica®, GraphPad Prism, JMP®, and Microsoft Excel.

For the Biological Assay Package, the datasets to be verified are based on literature like Finney1 and the European Pharmacopoeia2. For use cases not covered by literature, datasets are based on empirical values or simulated based on real datasets.

For settings that cannot be replicated in other software products, such as the handling of outliers during calculation or the logic according to which the test severity is evaluated, the expected result is documented in the verified dataset.

Data protection mechanism

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).

To ensure the reliability and trustworthiness of OQ document data, the OQ process utilizes the data protection mechanism of the PLA 3.0 document export function, as shown in the following figure:
Data protection mechanism of the OQ process
Figure 2. Data protection mechanism of the OQ process

  • Each OQ document is individually secured by an XML signature.

  • A hash value is created and assigned as a cryptographic checksum to each signed OQ document.

  • The OQ package is encrypted using the AES-EAX block cipher mode of operation.

Note: XML signatures applied by PLA 3.0 follow the recommendations of the World Wide Web Consortium (W3C). The keys used for signing the OQ documents and encrypting the OQ package are private and known only to Stegmann Systems.

Certificate of Qualification

If no deviations are detected, the OQ process creates a certificate.

How-to video

The following video shows how you execute the OQ in PLA 3.0:

1 Finney, David J. 1978. Statistical method in biological assay, 3rd edition. London: Charles Griffin and Company Ltd.
2 Council of Europe. European Pharmacopoeia 6.0. Chapter 5.3: Statistical analysis of results of biological assays and tests. Strasbourg: 2008.