Validation (IQ, OQ, PQ)

PLA 3.0 ready for GAMP

As calculations in PLA 3.0 are non-configurable and always performed within the verified range, it can be categorized as an ISPE GAMP® 5 category 3 solution (go to our Help Center to read more about verification and validation). PLA 3.0 runs a fully automated Installation Qualification (IQ) and Operational Qualification (OQ), and a semi-automated (with your own data) Performance Qualification (PQ). To perform an IQ, OQ and PQ the 'PLA 3.0 Validation Package' is required.

After you installed PLA 3.0 and activated the 'PLA 3.0 Validation Package', run the IQ or OQ fully automatically with only one click, and the PQ using your data. Afterward, you can generate your certificate.

Installation Qualification (IQ)

Installation Qualification (IQ) is a process in which the installation of a new piece of equipment or system is qualified to ensure that it has been installed properly according to the manufacturer's specifications, industry standards and regulatory requirements

For PLA 3.0 this means that the IQ (by PLA 3.0 Validation Package) validates the completeness and correctness of the PLA 3.0 installation. You can run it with just one click fully automatically

Operational Qualification (OQ)

Operational Qualification (OQ) is a process in which the performance of automated equipment or systems is qualified to ensure that they are operating in accordance with their design specifications, industry standards, and regulatory requirements.
The OQ is typically the second step in the validation process of automated equipment or systems, following Installation Qualification (IQ). It involves testing and verifying that the equipment or system is capable of performing its intended functions in a reliable and consistent manner, and that it meets the user's requirements

For PLA 3.0 this means the OQ validates the correctness of mathematical calculations performed by PLA 3.0 on the target system, using data sets verified by Stegmann Systems. You can run it (like IQ) fully automatically with just one click

Performance Qualification (PQ)

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)