IQ confirms the integration platform and its runtime are installed and configured as specified, with qualified non-production environments used for testing. OQ tests that each flow maps, reconciles, and handles exceptions as designed, including failure and retry cases. PQ shows the flow performs correctly under production-like conditions and data volumes over a sustained period.

Start with a risk and impact assessment that classifies each interface by what it does to a regulated record. Then build the controls into the flow: capture the original before transformation, map through versioned definitions, reconcile what arrived against what was sent, route failures to an exception path, and keep an audit trail. Change control keeps the interface validated after go-live.

Part 11 governs electronic records and signatures, and a record keeps that status while it moves. The integration must carry the signed record and its metadata intact and attributable. It should never regenerate a signature or apply a new one. Signing stays in the system of record.

Yes. GAMP 5 scopes validation to risk, not to whether a system has a user interface. An integration platform that handles regulated data is in scope, and the effort it needs follows from a documented risk and impact assessment of each interface.

Yes, when it creates, modifies, or moves a regulated record. An integration that carries batch results, release status, or patient-linked data is a computerized system in its own right. Validating the source and target systems does not cover what happens to the record in transit.