IQ, OQ, PQ Qualification

IQ — Installation Qualification

IQ verifies that the system is installed correctly per the design specifications. Covers hardware installation, software installation, network configuration, environmental conditions.

OQ — Operational Qualification

OQ verifies that the system operates as specified in the FDS. Covers functional testing, error handling, security testing, audit trail testing.

PQ — Performance Qualification

PQ verifies that the system performs as required in the production environment. Covers user acceptance testing, performance under load, integration with the production environment.

Qualification execution

The qualification execution is led by the client team with senior review by the practice. The practice supports the protocol authoring, the test execution oversight, the deviation management, and the final qualification summary report.

How to use this page

Use this IQ, OQ, PQ Qualification page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.

Evidence to prepare

For IQ, OQ, PQ Qualification, prepare the records, owners, risks and decision criteria linked to iq — installation qualification, oq — operational qualification, pq — performance qualification, qualification execution. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.

Frequently asked questions