Performance Qualification (PQ) is a process in which the performance of a system or equipment is qualified to ensure that it is capable of consistently and reliably producing the desired results under normal operating conditions.
PQ is typically the third and final step in the validation process of a new system or equipment, following IQ and OQ. It involves testing the system or equipment under actual or simulated operating conditions to demonstrate that it can consistently meet its performance requirements and specifications.
For PLA 3.0 this means that customers can validate PLA 3.0 using their own verified data sets. To do so, customers use PLA 3.0 to set up and calculate the data sets they want to use for validation. Using the PQ process, they create 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 which can be used for
- Requalification of the original workstation, for example, after changing the hardware or updating PLA 3.0 or other software components
- Qualification of additional workstations in the target environment
- Qualification of external installations (e.g., CROs)