FAT Audits

The most cost-effective time to catch an equipment defect is before it leaves the vendor's factory. Once equipment is on site, a defect means rework, delay and disruption to your qualification timeline; caught at the Factory Acceptance Test, the same defect is the vendor's problem to fix before shipment. PharmExpert performs independent FAT audits — witnessing and verifying that manufacturing equipment, utilities and automated systems meet the user requirement specification and design before shipment, installation and qualification.

Acting as your representative at the supplier's site, our specialists review the URS and design documents, witness functional and design testing against the vendor's protocol, and verify the build — materials of construction, instrumentation, automation and GMP/GAMP documentation. We confirm not only that the equipment works, but that the evidence and documentation will support the commissioning and qualification that follow.

Defects and gaps are captured in a managed punch-list with clear vendor corrective actions, so accountability stays where it belongs until issues are resolved. This protects both your capital and your schedule, and it sets up a smoother, leveraged commissioning and qualification under a modern ASTM E2500 approach — because much of the verification has already been done and documented at the source.

Our global pool means we can witness FATs at vendor sites worldwide, giving smaller and mid-sized organizations the same independent oversight that large pharma applies as standard. The deliverable is a clear FAT report with witnessed-test results, the punch-list, a specification-conformance assessment, and a ship-or-hold recommendation.