Performance Qualification

The Performance Qualification process (PQ process) of the PLA 3.0 Validation Package verifies the correctness of mathematical calculations performed by PLA 3.0 on the target systems, using datasets verified by the customer.

Customers use PLA 3.0 to set up and calculate the datasets they want to use for validation. Using the PQ process, they create Performance Qualification documents (PQ documents) that include the data setup and the calculation results. In the last step, they export the PQ documents as a Performance Qualification package (PQ package).

Customers can use the PQ process for the following purposes:

• Requalification of original workstation
• Qualification of additional workstations
• Qualification of external installations

Requalification of original workstation

When changing the hardware of the original workstation or updating PLA 3.0 or other software components, requalifying the original workstation is necessary to ensure that the qualified status is still valid.

Qualification of additional workstations

Once a workstation in the customer environment is qualified, the dataset used for qualification can be used to qualify additional workstations in the same environment.

Qualification of external installations

Once a workstation in the customer environment is qualified, the dataset used for qualification can be used to qualify installations outside of the customer environment. This can be necessary, for example, when working together with Contract Research Organizations (CRO).

Data protection mechanism

The PQ process of the PLA 3.0 Validation Package employs the same data protection mechanism as the OQ process, with the exception that the keys used for signing the PQ documents and encrypting the PQ package are public.

Certificate of Qualification

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