Installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) are the classic stages of qualifying equipment, utilities, facilities and computerised systems.
- IQ verifies that the system has been delivered and installed according to its specification — components, versions, configuration, documentation and environment.
- OQ verifies that it operates as intended across its specified operating ranges, including alarms, limits, security and error handling.
- PQ verifies that it performs consistently and reproducibly under routine conditions, with real users, real procedures and representative data or product.
For equipment, these stages are usually preceded by design qualification (DQ) and factory or site acceptance tests. For computerised systems, GAMP 5 allows the same verification to be organised differently — for example combining stages or relying on supplier testing — as long as requirements are verified traceably and according to risk.
Why it matters in GMP
EU GMP Annex 15 describes the qualification of equipment, facilities and utilities, and Annex 11 requires computerised systems to be validated. Inspectors expect each qualification stage to have an approved protocol, executed results with deviations recorded and resolved, and a report that releases the system for use.
- Approve the protocol before execution, and the report after.
- Record every failed test step as a deviation and resolve it.
- Trace every test back to a requirement.
How Swat iQua Suite supports your validation
Swat iQua Suite supports your qualification work with its computerised system assurance register, which traces approved requirements to test cases and executions and reports coverage, with built-in Part 11 controls, and with implementation and validation support from our team during go-live.